Praxis Klinische Forschung Berlin
Praxis Klinische Forschung Berlin

Studienliste

Eudra-CT Nr. Sponsor Studienname Indikation Phase Kurztitel Start Date global End Titel
2016-001304-37 GlaxoSmithKline 205715 Asthma III   November 16 ongoing A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma
2016-000154-34 Pearl Therapeutics, Inc. PT009002 COPD III Telos November 16 ongoing A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®,as an Active Control, on Lung Function over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
2015-005444-33 AstraZeneca AB D6571C00001 COPD III Amplify Mai 16 ongoing A 24 week treatment, multicenter, randomized, double blinded, double dummy, parallel-group, clinical trial evaluating the efficacy and safety of aclidinium bromide 400 _g/formoterol fumarate 12 _g fixed-dose combination BID compared with each monotherapy (aclidinium bromide 400 _g BID and formoterol fumarate 12 _g BID) and tiotropium 18 _g QD when administered to patients with stable chronic obstructive pulmonary disease.
2015-005406-11 AstraZeneca AB D1683C00005 Type 2 diabetes mellitus III   Mai 16 ongoing A Multi-Center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered with Dapagliflozin 5mg compared to Saxagliptin 5mg or Dapagliflozin 5mg all given as Add-on therapy to Metformin in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Alone
2015-002974-20 Boehringer Ingelheim Pharma GmbH & Co. KG 1237.28 COPD IV   August 16 ongoing A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 µg) compared with tiotropium (5 µg), both delivered by the Respimat® Inhaler, on breathlessness during the three minute Constant Speed Shuttle Test (3min CSST) in patients with Chronic Obstructive Pulmonary Disease (COPD)
2015-002529-21 Novartis Pharma Services AG CQVM149B2301 Asthma III Palladium Dezember 15 ongoing A multicenter randomized 52 week treatment double-blind, triple dummy parallel group study to assess the efficacy and safety of QMF149 compared to mometasone furoate in patients with asthma
2015-002376-24 AstraZeneca AB D1689C00014 Type 2 diabetes mellitus IV   Oktober 15 ongoing A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared with Sulphonylurea all given as Add-on Therapy to Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
2015-001778-17 GlaxoSmithKline 201190 Herpes Zoster Vaccination IIIB ZOSTER-049 EXT:006-022 Juni 16 ongoing A phase IIIb, open-label, multi-country, multi-centre, long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine and assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.
2015-001409-15 GlaxoSmithKline 201012 COPD II   Januar 16 Juli 16 A Dose-Finding Study of batefenterol (GSK961081) via Dry Powder Inhaler in Patients with COPD.
2015-000965-30 GlaxoSmithKline 204486 Herpes Zoster Vaccination III Zoster-056 Juli 16 ongoing A Phase IIIB, non-randomized, open-label, multi-country, multi-centric cross-vaccination study to evaluate the safety of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine when administered intramuscularly on a two-dose schedule to subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies.
2014_001449_26 Seikagaku Corporation 6603/1132 Lumbar Disc Herniation III   Januar 15 ongoing A Multicenter, Open-label Study of SI-6603 in Patients with Lumbar Disc Herniation (Phase III)
2014-005671-92 Pearl Therapeutics, Inc. PT010005 COPD III   Oktober 15 ongoing A Randomized, Double Blind, Multi Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52 Week Treatment Period in Subjects With Moderate to Very Severe COPD
2014-004940-36 sanofi-aventis recherche et developpement EFC13579 Asthma III Liberty Asthma Quest August 15 ongoing A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Persistent Asthma (Liberty Asthma Quest)
2014-004715-37 AstraZeneca M-34273-46 COPD IV   April 15 November 15 A randomised, double blind, placebo controlled, parallel study to assess the benefits of aclidinium bromide in the relief of COPD (Chronic obstructive pulmonary disease) symptoms including cough when administered to patients with COPD
2014-004712-10 Pearl Therapeutics, Inc. PT003014 COPD III   Juli 15 completed A Randomized, Double Blind, Chronic Dosing (24 Weeks), Placebo Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate to Very Severe COPD, Compared with Placebo
2014-004427-40 AstraZeneca D3250C00032 Asthma III Bise Februar 15 Oct 15 A Multicentre, Randomized, Double-blind, Parallel Group, Placebo- controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients with Mild to Moderate Persistent Asthma
2014-003808-77 GlaxoSmithKline 201543 Asthma II   September 15 ongoing A multi-centre, randomised, double-blind, placebo-controlled, crossover study to investigate the efficacy, safety, and tolerability of repeat doses of inhaled GSK2269557 in adults with persistent, uncontrolled asthma
2014-002275-28 Boehringer Ingelheim Pharma GmbH & Co. KG BI1237.19 COPD IIIB Dynagito März 15 ongoing A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO]
2014-002253-19 GlaxoSmithKline 201378 Asthma III   Februar 15 ongoing A randomized, double-blind, double-dummy, parallel group, multicenter study of once daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, twice daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and twice daily Fluticasone Propionate 250 mcg Inhalation Powder in the treatment of persistent asthma in adults and adolescents already adequately controlled on twice-daily inhaled corticosteroid and long-acting beta2 agonist.
2014-001976-75 Amgen (EUROPE) GmbH 20130385 Dyslipidemia III EBBINGHAUS Dezember 14 November 16 A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients with Clinically Evident Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial Evolocumab (AMG 145)
2014-001704-22 Chiesi Farmaceutici S.p.A. CCD-05993AA1-08 COPD III Tribute Juni 15 ongoing A study to evaluate whether a new inhaled medicine (combination of beclometasone plus formoterol plus glycopyrronium) works as well as a licensed medicine (combination of indacaterol and glycopyrronium) in patients with chronic obstructive pulmonary disease.
2014-001086-27 AstraZeneca AB D3250C00021 Asthma III Bora Oktober 14 ongoing A Multicenter, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting _2 Agonist (BORA)
2014-00051-81 GlaxoSmithKline HZA116492 Asthma IIIB   April 16 ongoing A 6-month, open label, randomised, efficacy study to evaluate fluticasone furoate (FF, GW685689) vilanterol (VI, GW642444) Inhalation Powder deliered once daily via the Dry Powder Inhaler Ellipta copared with usual ICS/LABA maintenance therapy deliered by Dry Powder Inhaler in subjects with Persistent Asthma
2013-004888-31 Mundipharma Research Limited OXN3508 Pain III   Oktober 14 August 16 A randomised, double-blind, double-dummy, cross-over multicenter study to demonstrate equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as achieved with the higher OXN PR tablet strengths (OXN60/30 mg PR, OXN80/40 mg PR) twice daily compared to the identical daily dose taken as a combination of lower tablet strengths in subjects with non-malignant or malignant pain that requires around-the-clock opioid therapy.
2013-004590-27 AstraZeneca AB D3251C00003 COPD III Galathea Juli 14 ongoing Randomised, double-blind, 56 week placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe COPD with a history of exacerbations (GALATHEA)
2013-004548-44 GlaxoSmithKline MID200820 COPD III   April 14 Juli 15 A 12-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) 100/25 mcg Once Daily Compared with Vilanterol Inhalation Powder (VI) 25 mcg Once Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
2013-004548-44 GlaxoSmithKline NKI1103334 Primary insomnia II   Dezember 07 Mai 08 A multi-centre, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of GW597599 and GR205171 on sleep continuity, PSG sleep recordings, subjective sleep assessment and daytime cognitive function in subjects with primary insomnia
2013-004473-28 AstraZeneca AB D589SC00003 Asthma III Sygma II Dezember 14 ongoing A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 _g ‘as needed’ compared with Pulmicort (budesonide) Turbuhaler 200 _g twice daily plus terbutaline Turbuhaler 0.4 mg ‘as needed’
2013-003519-23 AstraZeneca AB D513BC00001 Type 2 diabetes mellitus III Themis Mai 14 ongoing A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus
2013-003397-27 Teva Branded Pharmaceutical Products R&D, Inc. BDB-AS-301 Persistent Asthma III   April 14 November 14 A Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group, 12 Week Clinical Study to Assess the Efficacy and Safety Of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered via Breath Actuated Inhaler (BAI) or Metered Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older with Persistent Asthma
2013-003127-11 Novartis Pharma Services AG CQVA149A3401 COPD IV   Mai 14 April 16 A prospective, multicenter, 12-week, randomized open-label study to evaluate the efficacy and safety of glycopyrronium (50 micrograms o.d.) or indacaterol maleate and glycopyrronium bromide fixed-dose combination (110/50 micrograms o.d.) regarding symptoms and health status in patients with moderate chronic obstructive pulmonary disease (COPD) switching from treatment with any standard COPD regimen
2013-003043-36 CHIESI FARMACEUTICI S.p.A. CCD-1206-PR-0088 Asthma II TRISKEL Mai 14 März 15 A multicentre, randomised, double-blind, active-controlled, 3-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of CHF 5259 (glycopyrrolate) plus Foster® 100/6µg (fixed combination of beclomethasone dipropionate plus formoterol) in a metered dose inhaler for the treatment of patients with uncontrolled asthma under medium doses of inhaled corticosteroids plus long-acting _2-agonists
2013-002671-18 Boehringer Ingelheim Pharma GmbH & Co. KG 1237.16 COPD III Physacto Juni 14 Oktober 15 An explorarory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD
2013-002652-32 Boehringer Ingelheim Pharma GmbH & Co. KG 1237.7 COPD III   Dezember 13 Juni 14 A randomised, placebo-controlled, double-blind, single dose, cross-over study to evaluate the efficacy and safety of orally inhaled tiotropium + olodaterol as both a fixed dose combination and a free combination (both delivered by the Respimat® inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD)
2013-002507-34 Genkyotex Innovation SA GSN000200 Type 2 Diabetes and Albuminuria II   Februar 14 März 15 A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients with Type 2 Diabetes and Albuminuria
2013-002163-26 AstraZeneca D3250C00018 Asthma III Calima Oktober 13 März 16 A multicentre, randomised, double-blind, parallel group, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of benralizumab in asthmatic adults and adolescents inadequatley controlled on inhaled corticosteroid plus long-acting beta2 agonist (CALIMA)
2013-001835-33 Novartis Pharma Services AG CLCZ696B2228 Chronic heart failure II   Dezember 13 August 14 A multicenter, randomized, double-blind, parallel group study to assess the safety and tolerability of initiating LCZ696 in heart failure patients comparing two titration regimens
2013-001827-38 GlaxoSmithKline DB2116961 COPD III   August 14 Mai 15 A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD
2013-000473-68 Grünenthal GmbH KF6005/08 Diabetic neuropathy II   September 13 Januar 15 Efficacy, safety and tolerability of multiple doses of oral cebranopadol in subjects with moderate to severe chronic pain due to diabetic peripheral neuropathy
2013-000372-15 GlaxoSmithKline 117036 / Zoster-004 Zoster & Flu vaccination III   September 13 März 15 A phase III, randomized, open-label, multicentre clinical trial to assess the immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ quadrivalent influenza vaccine FLU-D-QIV (GSK2321138A) versus separate administration of the two vaccines in adults aged 50 years and older
2013-000081-11 Teva Branded Pharmaceutical Products R&D, Inc. BFS-AS-306 Persistent Asthma III   August 13 März 14 "A 12-Week Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® 160/4.5 mcg Inhalation Powder Versus SYMBICORT® TURBOHALER® 200/6 mcg in Adult and Adolescent Patients with Persistent Asthma."
2012-005848-21 AbbVie Inc. M11-352 Diabetic nephropathy III Sonar Dezember 13 ongoing A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy with Atrasentan
2012-004801-28 GlaxoSmithKline HZC102972 COPD IV Fulfill Dezember 13 Oktober 16 Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD)
2012-004357-83 Amgen (EUROPE) GmbH 20120138 Primary hyperlipidaemia and mixed dyslipidaemia III OSLER Juni 13 ongoing A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
2012-004162-17 Mundipharma Research Limited FLT3509 COPD III   Oktober 13 Mai 16 A randomised, double-blind, double dummy, parallel group study comparing Fluticasone propionate / formoterol fumarate (flutiform®) 250/10 _g (2 puffs BID) and flutiform® 125/5 _g (2 puffs BID) versus Formoterol fumarate dihydrate (Atimos®) 12 _g (1 puff BID) in subjects with chronic obstructive pulmonary disease (COPD)
2012-003973-24 GlaxoSmithKline ZEP117115 COPD III   Januar 13 Januar 14 A Multicenter Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily with Tiotropium 18 mcg Once Daily over 24 Weeks in Subjects with Chronic Obstructive Pulmonary Disease (COPD
2012-003966-42 Pulmagen Therapeutics LLP ADC3680-07 Astma II   Mai 13 Dezember 14 A Randomised, Double Blind, Placebo-Controlled, Multi-Centre, Parallel Group Study to Evaluate the Efficacy and Safety of ADC3680 Administered Once Daily as an Add-On Therapy to Inhaled Corticosteroids and when Co-Administered with Montelukast in Subjects with Inadequately-Controlled Asthma.
2012-003106-27 GlaxoSmithKline RLV116974 Chronic Bronchitis and/or Emphysema III   November 12 Juli 13 A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD
2012-002943-11 Grünenthal GmbH KF5503/60 low back pain with neuropathic pain IV   Februar 13 Januar 14 Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus oxycodone/naloxone PR in non-opioid pre-treated subjects with uncontrolled severe chronic low back pain with a neuropathic pain component
2012-002797-32 GlaxoSmithKline HZA116863 Asthma III   November 12 Oktober 13 A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Flutic...
2012-002797-32 GlaxoSmithKline HZA116863 Asthma III   Oktober 12 Januar 13 A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
2012-001772-11 Mundipharma Research GmbH & Co. KG OXN2505 Pain II   Dezember 13 Februar 15 An exploratory, double-blind, double-dummy, randomised, 2-period, crossover, Phase IIa study to assess the influence of oxycodone/naloxone prolonged-release tablets (OXN PR) and oxycodone prolonged-release tablets (OxyPR) on intestinal microbiota and other gastrointestinal parameters in subjects suffering from non-malignant pain requiring an equivalent of 20 – 50 mg oxycodone prolonged-release per day
2012-001398-97 Amgen (EUROPE) GmbH 20110118 Dyslipidemia III Fourrier Januar 13 November 16 A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease. FOURIER - Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk
2012-001363-70 Amgen Inc. 20110115 Primary Hypercholesterolemia and Mixed Dyslipidemia III LAPLACE - 2 Januar 13 Dezember 13 A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
2012-000524-18 GlaxoSmithKline DB2116134 COPD III   Mai 13 Oktober 13 A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD
2011-005244-95 GlaxoSmithKline ALA116402 Asthma II   Juni 12 Februar 13 A multi-national, randomized, double-blind, placebo-controlled, 3-period crossover study with GSK 573719 as monotherapy in adult subjects with asthma
2011-003890-27 Boehringer Ingelheim Pharma GmbH & Co. KG 69.52 acute low back pain III   September 12 April 13 "A multi-centre, double-blind, randomised, parallel group study to assess the efficacy and safety of multiple doses of topically applied hyperemisation-inducing ointment (2 cm ointment line per application
2011-002451-33 GlaxoSmithKline HZC115805 COPD III   Mai 12 Dezember 12 A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once-Daily via a Novel Dry Powder Inhaler Compared with Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily via the HandiHaler® in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Diseas
2011-002276-16 Boehringer Ingelheim Pharma GmbH & Co. KG 1218.60 Type 2 diabetes mellitus IV   November 11 März 13 A randomised, double-blind, double-dummy active-comparator controlled study investigating the efficacy and safety of Linagliptin co-administered with metformin QD at evening time versus metformin BID over 14 weeks in treatment naive type 2 diabetes and insufficient glycaemic control
2011-001644-29 GlaxoSmithKline SAS115359 Asthma IV AUSTRI April 12 Juni 15 A Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.
2011-001007-12 Merck Sharp & Dohme Corp. MK-0524A-133 Primary Hypercholesterolemia III   März 11 Oktober 13 "This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant [ERN/LRPT (MK-0524A)] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin, atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.
2010-024435-16 GlaxoSmithKline HZC115247 COPD III   Mai 11 August 12 A 12-week study to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI) on arterial stiffness compared with Tiotropium bromide 18 mcg delivered once daily via a HandiHaler in subjects with Chronic Obstructive Pulmonary Disease (COPD)
2010-024179-18 Pfizer INC. A0221094 OAB IV   August 11 Mai 12 A 14 WEEK RANDOMIZED PARALLEL GROUP PLACEBO-CONTROLLED DOUBLE-BLIND MULTICENTRE STUDY OF FESOTERODINE 8 MG IN OVERACTIVE BLADDER PATIENTS WITH SUB-OPTIMAL RESPONSE TO TOLTERODINE 4 MG ER
2010-023601-35 Teva Branded Pharmaceutical Products R&D, Inc. FpS-AS-202 Severe Persistent Asthma II   Februar 13 Oktober 13 A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Orally Twice Daily compared with Placebo in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on High dose Inhaled Corticosteroid Therapy
2010-023442-75 GlaxoSmithKline DB2114417 COPD III   April 11 Dezember 14 An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A (COPD)
2010-023418-29 GlaxoSmithKline HZC113109 COPD III Masthead Februar 11 Dezember 11 HZC113109: A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
2010-023348-33 GlaxoSmithKline DB2113361 COPD III   April 11 April 12 A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease.
2010-023091-10 GlaxoSmithKline HZC113108 COPD III   April 11 November 14 A 24-week study to evaluate the effect of fluticasone furoate/ vilanterol 100/25 mcg Inhalation Powder delivered once-daily via a Novel Dry Powder Inhaler on arterial stiffness compared with placebo and vilanterol in subjects with Chronic Obstructive Pulmonary Disease (COPD).
2010-022796-62 GlaxoSmithKline MAB115032 COPD II   Dezember 10 September 11 A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects with Chronic Obstructive Pulmonary Disease (COPD
2010-021789-31 Pfizer INC. A3051139 smoking cessation IV   November 10 November 12 A PHASE 4 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF RE-TREATMENT WITH VARENICLINE IN SUBJECTS WHO ARE CURRENTLY SMOKING, AND WHO HAVE PREVIOUSLY TAKEN VARENICLINE
2010-021788-33 Pfizer INC. A3051075 smoking cessation IV   Juli 11 Juli 13 A PHASE 4, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VARENICLINE COMPARED TO PLACEBO FOR SMOKING CESSATION THROUGH REDUCTION
2010-021638-72 GlaxoSmithKline HZC113782 COPD III Summit Juni 11 Juli 15 A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.
2010-021069-63 Amylin Pharmaceuticals, LLC BCB109(H8O-MC-GWDQ) Type 2 diabetes mellitus IV EXSCEL Juni 11 ongoing A randomized, placebo, controlled clinical trial to evaluate cardiovascular outcomes after treatment with Exenatide Once Weekly in patients with type 2 diabetes mellitus
2010-021059-25 GlaxoSmithKline HZC113107 COPD III   Februar 11 Oktober 11 A 12-week study to evaluate the 24 hour pulmonary function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) once daily compared with Salmeterol/Fluticasone Propionate (FP) Inhalation Powder twice daily in subjects with Chronic Obstructive Pulmonary Disease (COPD)
2010-020945-28 Servier Institut de Recherches Internationales CL3-05985-018 Hypertension III   Dezember 10 Januar 13 Perindopril arginine / Amlodipin versus Valsartan/ Amlodipin antihypertensive strategies: Efficacy and safety in mild to moderate hypertensive patients. A randomised, double blind 6-month study followed by 8-month open label long-term follow-up with Perindopril arginine/Amlodipin
2010-019998-14 Grünenthal GmbH KF5503/58 low backpain III, IV   Februar 11 Januar 12 Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain...
2010-019872-65 MSD SHARP & DOHME GMBH MK-0663-108 Ankylosing Spondylitis III   Oktober 10 November 14 A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis
2010-019871-31 MSD SHARP & DOHME GMBH MK-0663-107 Rheumatoid arthritis III   Oktober 10 August 14 A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis
2010-019798-13 Bristol-Myers Squibb MB102-077 Type 2 Diabetes III   Mai 11 Februar 13 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication
2010-019797-32 Bristol-Myers Squibb MB102-073 Type 2 Diabetes III   Dezember 10 Februar 14 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB
2010-019791-73 sanofi-aventis recherche et developpement EFC11405 Atrial Fibrillation III Pallas August 10 November 11 A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors
2010-019590-15 GlaxoSmithKline HZA106827 Asthma III   Oktober 10 Oktober 11 A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents.
2010-018414-69 Merck & Co., Inc. 4305-029 Primary Insomnia III   Mai 10 November 11 A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study B
2010-018300-85 Menarini Ricerche S.p.A. NAK-04 IBS II IRIS 2 August 10 Mai 12 Double-blind, randomised, placebo-controlled, parallel-group phase II study to evaluate the effect of oral ibodutant in irritable bowel syndrome with diarrhoea (IBS-D) - The Iris-2 Study.
2009-018005-43 Boehringer Ingelheim Pharma GmbH & Co. KG 205.419 Asthma III   Juni 10 November 12 A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 and 5 _g once daily) compared with placebo and salmeterol HFA MDI (50 _g twice daily) over 24 weeks in patients with moderate persistent asthma
2009-017669-44 GlaxoSmithKline HZA 106851 Asthma II   April 10 September 10 Studie zur Wirkung von inhalativem Fluticasonfuroat/GW642444 versus Placebo auf die HypothalamusHypophysen-Nebennierenrinden-Achse bei erwachsenen Asthmatikern
2009-017358-10 AstraZeneca D1680C00003 Diabetes mellitus IV Savor Timi 53 Juni 10 Oktober 15 Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus. Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase IV Studie zur Beurteilung der Auswirkungen von Saxagliptin auf die Inzidenz kardiovaskulärer Todesfälle, Myokardinfarkten oder ischämischen Schlaganfällen bei Patienten mit Typ 2 Diabetes
2009-017242-30 AstraZeneca D5132C00001 Cardiovascular disease III Pegasus Timi November 10 Dezember 14 A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction
2009-016690-15 GlaxoSmithKline AC4113589 COPD II   Februar 10 Juli 10 "A randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of GSK573719 delivered once-daily over 28 days in subjects with COPD
2009-015988-13 Recordati S.p.A. REC15/2375-IT-CL0336 essential hypertension II   Januar 10 November 11 An international multicentre, randomized, parallel group, double-blind trial to evaluate different dose combinations of lercanidipine and enalapril in comparison with each component administered alone and with placebo in patients with essential hypertension.
2009-015834-31 Novartis Pharma Services AG CLCZ696B2314 chronic heart failure III PARADIGM-HF Dezember 09 Mai 14 A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction
2009-015791-94 GlaxoSmithKline 113077 / ZOSTER-022 Zoster vaccination III   Oktober 10 Juli 15 A phase III, randomized, observer-blind, placebo-controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK Biologicals’ gE/AS01B vaccine when administered intramuscularly on a 0, 2-month schedule in adults aged 70 years and older
2009-014543-36 GlaxoSmithKline AC4113073 COPD II   November 09 März 10 A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects with COPD
2009-013067-19 GlaxoSmithKline HZC112207 COPD III   Januar 10 Februar 11 A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Com...
2009-012772-27 Merck Sharp & Dohme Corp. 0524A-102 Dyslipidemia IV   November 09 Januar 11 A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Extended-Release (ER) Niacin and Laropiprant (ERN/LRPT) in Patients with Dyslipidemia
2009-011360-10 Servier Institut de Recherches Internationales CL3-16257-083 Cardiovascular disease III Signify Januar 10 Januar 14 Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study.
2009-010587-42 Amgen Inc., Thousand Oaks, CA Prolia / 20080099 bones density III Denosumab Dezember 09 Dezember 11 A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.
2008-008254-23 GlaxoSmithKline SIG 112851 Asthma IIa   Juli 09 September 09 A Randomised, Double-blind, Placebo-controlled, 2-way Crossover Study to Determine the Efficacy of Repeat Inhaled Doses of GW870086X on FEV1 in Mild to Moderate Asthmatics
2008-007831-41 Novartis Pharma Services AG CSPP100A2408 Hypertension IV   April 09 Juni 10 A twelve-week, randomized, double-blind, parallel group study to evaluate the prolonged efficacy and safety of aliskiren 300 mg compared to telmisartan 80 mg in mild to moderate hypertensive patients with 24-hour ambulatory blood pressure measurement after 1 week of treatment withdrawal.
2008-006625-14 Boehringer Ingelheim Pharma GmbH & Co. KG 1222.29 Asthma II   Januar 11 Dezember 11 Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered with the Respimat® Inhaler, after 3 Weeks of Olodaterol Once ...
2008-006345-72 GlaxoSmithKline NKI-111364 Primary insomnia II   April 09 September 09 A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/day) for the Treatment of Primary Insomnia in Adult Outpatients.
2008-005575-96 GlaxoSmithKline LPL100601 Atherosclerosis III Stability Dezember 08 Oktober 12 A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
2008-005030-73 GlaxoSmithKline AVD111960 Diabetes mellitus III   November 09 November 10 Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In Peopl...
2008-004522-16 Daiichi Sankyo Europe GmbH DU176b-C-U301 Atrial Fibrillation III Engage-AF Mai 09 Mai 13 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF DU-176B VERSUS WARFARIN IN SUBJECTS WITH ATRIAL FIBRILLATION – Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE-AF)
2008-004104-31 Novartis Pharma Services AG CSPP100F2301 Chronic heart failure III   Mai 09 Oktober 15 A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV)
2008-003791-22 sanofi-aventis recherche et developpement EFC10844 Insomnia III Eclipse Januar 09 Mai 09 Efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties: a 6-week, randomized, double-blind, placebo-controlled, polysomnography study
2008-003535-20 Daiichi Sankyo Europe GmbH CS8635-A-E303 Hypertension III   April 09 September 10 A RANDOMISED, DOUBLE-BLIND, ADD-ON STUDY OF HYDROCHLOROTHIAZIDE IN SUBJECTS WITH MODERATE TO SEVERE HYPERTENSION NOT ACHIEVING TARGET BLOOD PRESSURE ON OLMESARTAN MEDOXOMIL/AMLODIPINE FIXED DOSE COMBINATION 40/10 MG ALONE
2008-001281-16 GlaxoSmithKline 106372 / FLU NG-006 PRI Influenca na   August 08 Dezember 10 A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramusc...
2008-000908-91 AstraZeneca D1443L00044 Major depression III Ruby Oktober 08 August 09 A randomised, 6-week, multicentre, open-label, rater-blinded parallelgroup study comparing Quetiapine extended release monotherapy and augmentation with Lithium augmentation in patients with Treatment Resistant Depression
2008-000367-42 GlaxoSmithKline 110390 / Zoster-006 Zoster vaccination III   Oktober 10 Juli 15 A phase III, randomized, observer-blind, placebo-controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK Biologicals’ gE/AS01B vaccine when administered intramuscularly on a 0, 2-month schedule in adults aged 50 years and older.
2008-000214-71 Laboratorios Menarini S.A. (Menarini Group) NAK-03 irritable bowel syndrome II   August 08 Februar 09 Double blind, randomized, placebo-controlled, parallel group study to evaluate the effect of a 4-week treatment with oral doses of MEN15596 in irritable bowel syndrome.
2007-006562-15 GlaxoSmithKline FFU111439 Perennial Allergic Rhinitis (PAR) IV   März 08 Juni 08 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR
2007-006451-39 Pfizer INC. A0221046 overactive bladder IV   Juni 08 Oktober 10 12-week, randomized, double-blind, double-dummy, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Fesoterodine in coparison to Tolterodine ER in patients with overactive bladder
2007-006287-29 GlaxoSmithKline AC2110664 COPD II   Juni 08 Dezember 08 A Dose ranging study for GSK233705B delivered once daily in subjects with COPD.
2007-004459-13 GlaxoSmithKline FFA109685 Asthma II   Februar 08 November 08 A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose Inhaled Corticosteroid Therapy
2007-004020-20 Merck & Co., Inc. V211-022 Herpes zoster III   Dezember 07 Januar 10 A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of ZOSTAVAX™ in Subjects 50 to 59 Years of Age
2007-003684-41 Merck & Co., Inc. 6213-006-03 Primary Hypercholesterolemia II   Februar 08 Januar 09 A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Assess the Efficacy and Tolerability of MK-6213 Co-Administered with Atorvastatin in Patients with Primary Hypercholesterolemia
2007-002516-26 MSD SHARP & DOHME GMBH 0524-063 Hypercholesterolemia III MK-0524B Lipid Study September 07 August 08 A Multicenter, Randomized, Double-Blind, “Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.
2007-002017-39 MSD SHARP & DOHME GMBH 0524-067 Primary Hypercholesterolemia or Mixed Dyslipidemia IV   August 07 Juli 08 A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
2007-001922-28 Pfizer INC. A7941005 Type 2 Diabetes IIa   Oktober 07 Juni 08 A Phase 2A, Randomized, Placebo-controlled, Parallel group, Multiple-dose study to evaluate the Efficacy, Safety and Tolerability of 12-week oral administration of PF-00734200 tablets to subjects with Type 2 Diabetes Mellitus on stable treatment with Metformin
2007-001691-36 MSD SHARP & DOHME GMBH 0893-008 Type 2 Diabetes Mellitus II   Juli 07 Mai 08 A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose Range Finding Study in MK-0893 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.
2007-000145-35 MSD SHARP & DOHME GMBH 0431-803 Type 2 Diabetes Mellitus III   April 08 Oktober 09 A Phase III, Multicenter, Double-Blind, Randmoized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
2006-006935-38 Pfizer INC. A0221008 Overactive bladder III   Juli 07 Juli 08 12-WEEK, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE IN COMPARISON TO TOLTERODINE ER IN PATIENTS WITH OVERACTIVE BLADDER"
2006-006743-31 Dynavax Technologies Corporation HBV-10 Hepatitis B immunization III   Mai 07 Juli 08 A Phase III Safety and Efficacy Study to Compare Immune Responses following Injection with Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
2006-005914-10 GlaxoSmithKline CBA109389 Osteoarthritis of the Knee II   April 07 August 07 A Multicentre, Randomised, Double-blind, Placebo and Naproxen (500mg) BID controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 weeks in Adults with Osteoarthritis of the Knee
2006-005556-32 Menarini Ricerche S.p.A. CS866CM-B-E303 essential hypertension III   August 07 Mai 08 Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Essential Hypertension
2006-005477-22 GlaxoSmithKline 107495 H5N1-012 II   Juli 07 Oktober 08 A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules.
2006-005334-21 sanofi-aventis recherche et developpement DRI6938 smoking cessation II sursmoke Februar 07 April 08 A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-week treatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 an d10 mg / day as an aid to smoking cessation in cigarette smokers
2006-003730-15 Dainippon Sumitomo Pharma Europe Ltd. D3601113 OAB II   Januar 00 Mai 08 A 10-week randomised, double-blind, parallel-group, placebo-controlled phase 2 study to investigate the extent of symptom relief and the safety and tolerability of SMP-986 (20 mg, 40 mg, 80 mg and 120 mg) administered once daily for 8 weeks to patients with overactive bladder syndrome
2006-003548-42 Gilead Sciences, Inc DAR-312-E Hypertension III DORADO-AC-EX April 08 prematurely ended A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects with Resistant Hypertension Despite Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)
2006-003547-23 Gilead Sciences, Inc DAR-312 Hypertension III DORADO-AC September 07 August 09 A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More
2006-003107-39 MSD SHARP & DOHME GMBH 0524A-023 Hypercholesterolemia III   August 06 Februar 07 A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin
2006-002131-24 GlaxoSmithKline OXS107714 Primary insomnia IIa   September 06 Mai 07 A multi-centre, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of SB-649868 (10mf, 30 mg and 60 mg) on sleep contiuity, PSG sleep recordings, subjective sleep assessment and daytime cognitive function in subjects with primary insomnia.
2006-001281-16 GlaxoSmithKline 107217 (H5N1) influenza vaccine III   Juni 06 Oktober 06 A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine (split virus formulation containing 15 µg HA and adjuvanted with AS03) in adults aged 18 years and older
2006-000708-18 Servier Institut de Recherches Internationales CL3-16257-063 Hypertension III Shift Januar 07 Juni 10 Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction. A three-year randomised double-blind placebo-controlled international multicentre study.
2005-006118-17 GlaxoSmithKline B3I105940 IBS II   August 06 Juni 07 A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the beta3-Adrenergic Receptor Agonist Solabegron in Subjects with Irritable Bowel Syndrome
2005-006080-31 GlaxoSmithKline RRL106721 RLS na ROAD November 06 März 08 A Multicenter 3:1-randomized Placebo-controlled Double-blind Phase IIIb Study on the Effects of Ropinirole on Mood/(Subclinical) Depression in the Therapy of Patients With Moderate to Severe Idiopathic RLS in Germany
2005-005431-97 GlaxoSmithKline B3P104833 OAB II   März 06 Februar 07 An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women with Overactive Bladder
2005-005372-32 GlaxoSmithKline ROR104836 RLS IV   März 06 November 08 A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.
2005-005278-59 Amgen Inc. 20050222 Heart Failure III RED-HF™ Trial September 06 Oktober 12 A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symp...
2005-005093-70 MSD SHARP & DOHME GMBH 0524A-020 mixed Hyperlipidemia III   Dezember 05 Dezember 06 A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK-0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
2005-004411-29 Pfizer INC. A3051049 smoking cessation III   März 06 Oktober 08 A 12-week, double-blind, placebo-controlled, multicenter study with a 40 week follow-up evaluating the safety and efficacy of Varenicline tartrate 1 mg BID for smoking cessation in subjects with cardiovascular disease
2005-003590-24 GlaxoSmithKline LPL104884 Atherosclerosis II   Januar 06 September 06 A multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeks
2005-003249-15 BIONORICA AG E-BRO-3 Acute bronchitis IV   September 05 März 06 Efficacy and tolerability of Bronchipret® Saft for the treatment of acute bronchitis in adults A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase IV study
2005-002942-20 sanofi-aventis recherche et developpement EFC5826 Cardiovascular disease III Crescendo Januar 06 April 09 Randomized, multinational, multicenter, double-blind, placebo-controlled, two-arm parallel grouptrial of rimonabant 20 mg OD for reducing the risk of major cardiovasular events in abdominally obese patients with clustering risk factors
2005-002364-29 MSD SHARP & DOHME GMBH MK-0364/ 015 Obesity III   August 05 Oktober 08 A Two Year Study to Assess the Efficacy, Safety, and Tolerability of MK-0364 in Obese Patients Followed by a 1-Year Extension
2005-001256-20 GlaxoSmithKline ITI 101724 Non-valvular Atrial Fibrillation II   November 05 Dezember 12 Non-valvular Atrial Fibrillation
2005-000184-25 GlaxoSmithKline SK&F-101468/204 RLS III   Januar 06 Dezember 06 A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared with Ropinirole Immediate Release (IR) Tablets in Subjects with Restless Legs Syndrome (RLS)
2005-000149-12 GlaxoSmithKline CXA30007 Osteoarthritis of the Knee III   Februar 05 September 06 A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee (CXA30007)
2005-000039-73 Novartis Pharma Services AG CSPP100A2327 Hypertension III   Juli 05 September 06 An 8-week randomized, double-blind, parallel group, multi-center, placebo and active controlled dose escalation study to evaluate the efficacy and safety of aliskiren (150 mg and 300 mg) administered alone and in combination with valsartan (160 mg and 320 mg) in patients with hypertension
2004-005115-29 GlaxoSmithKline RA1104046 Rheumatoid arthritis II   September 05 August 06 A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship
2004-004863-32 Berlin-Chemie Menarini BCBE/04/NEB-PAO/087 essential hypertension and PAVK IV   März 06 März 09 EFFECTS OF NEBIVOLOL ON THE WALKING ABILITY IN PATIENTS WITH ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATION
2004-004744-43 GlaxoSmithKline FFR30007 idiopathic Rhinitis III   Juni 05 Dezember 05 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic Rhinitis
2004-004308-19 AXCAN PHARMA Inc. ITOFD04-04 functional dyspepsia III   Februar 05 September 06 A multicentre, open-label study to evaluate the long-term safety and efficacy of itopride HCl in patients suffering from functional dyspepsia
2004-004014-16 Novartis Pharma Services AG CSPP100A2313 Stable Heart Failure III Aloft Juni 07 März 07 A twelve-week, randomized, double-blind, multi-center, placebo controlled, parallel group study to evaluate the safety and efficacy of aliskiren 150 mg when added to standard therapy in patients with stable heart failure
2004-002166-38 Boehringer Ingelheim International GmbH BI 205.301 COPD / Asthma IV   Dezember 04 November 06 A 12-week randomised, double blind, placebo-controlled, parallel group trial evaluating the efficacy and safety of inhaled tiotropium 18 _g q.d. in patients with COPD and a concomitant diagnosis of asthma
2004-002159-16 MSD SHARP & DOHME GMBH 0431-024 Type 2 Diabetes Mellitus III   Januar 05 Juni 06 A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
2004-001959-11 Servier Institut de Recherches Internationales CL3-16257-056 Cardiovascular disease III Beautiful März 05 Februar 08 Effects of ivabradine on cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction. A three-year randomised double-blind placebo-controlled international multicentre study.
2004-000882-36 GlaxoSmithKline PAD 20001 Dyslipidaemia II   August 05 Juni 06 A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc
_ GlaxoSmithKline 101468/192 RLS na   Juni 02 Juli 04 A 52 week open-label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS)
_ GlaxoSmithKline MID201909 Asthma IV   Juni 15 August 15 An open-label study investigating critical and overall errors following 14 days of treatment with SERETIDE Metered Dose Inhaler (EVOHALER) in adult subjects with controlled asthma currently using the SERETIDE DISKUS Inhaler.
_ GlaxoSmithKline OHB100775 RLS II   April 04 November 04 A four week, randomised, double blind, placebo-controlled Study to evaluate the Efficacy, Safety and Tloerability of GW353162 in Patients with Restless Legs Syndrome (RLS) with Periodic Limb Movemts during Sleep (PLMS)
_ GlaxoSmithKline SB712753/003 Type 2 diabetes mellitus III   Juni 03 Dezember 04 A Phase III multi-centre, double -b blind, randomised, parallel group, dose escalation study comparing the effects of 32 weeks administration of Avandamet and metformin on HbA1c targets in subjects with mild type 2 diabetes mellitus
_ GlaxoSmithKline SB-782528-028 Arterielle Hypertonus und Erektile Dysfunktion III   Januar 03 Juli 04 A randomised, double-blind, parallel-group, placebo-controlled study evaluating the efficacy and safety of vardenafil administered for 12 weeks in a flexible-dose regimen compared to placebo in men with arterial hypertension and erectile dysfunction
_ Pfizer INC. A6121122 PPBC IV   Juli 04 Dezember 05 A global Phase IV, Double-blind, Placebo-controlled, randomized Trial to Evaluate the Effectiveness of Detrusitol SR 4mg on Patient's Perception of Bladder Condition (PPBC)
_ Pfizer INC. 066-192 C. Pneumoniae-Exposition und Arterienkrankheit n.a.   November 97 November 99 Eine randomisierte, doppelblinde klinische Prüfung mit Placebokontrolle zur Untersuchung der Wirkung von wöchentliche verabreichtem Azithromycin audf die Inzidenz einer Koronararterienerkrankung bei Patienten mit nachweislicher C.Pneumoniae Exposition
_ Pfizer INC. A137011 Dranginkontinenz III   April 00 n.a. Eine multizentrische, doppelblinde, randomisierte und placebokontrollierte Phase-III-Studie mit Parallelgruppen zur Untersuchung von Darifenacin versus Tolterodin bei Patienten mit instabiler Harnblase (Dranginkontinenz)
_ Pfizer INC. A1371042 Dranginkontinenz n.a.   April 02 Dezember 04 multizentrische, offene Langzeitstudie zur Untersuchung von Darifenacin bei Patienten mit instabeiler Harnblase (Dranginkontinenz)
_ Pfizer INC. A4451007 Reizdarmsyndrom n.a.   November 03 November 04 Eine multizentrische, doppelblinde, randomisierte, placebo-kontrollierte Studie mit parallelen Gruppen zur Untersuchung der Wirksamkeit von PD-217,014 bei der Behandlung des Reizdarmsyndroms.
_ Pfizer INC. A5091018 gemischte Dyslipidämie III   Juni 04 September 06 multizentrische, randomisierte, doppelblinde, pazebokontrollierte klinische Prüfung der Phase 3 im Parallelgruppendiesign zum Vergleich der Wirksamkeit, Sicherheit und Verträglichkeit der einmal täglichen oralen Gabe einer fixen Kombination von Torcetrapid und Atorvastatin mite einer Atorvastatin-Monotherapie oder Placebo bei Patienten mit gemischter Dyslipidämie (Frederickson Typ IIa und II b)
_ Pfizer INC. A6141079 Heart Failure n.a. Emphasis-HF Februar 06 Januar 07 The Effect of Eperenone vers. Placebo on Cardiovascular Mortality and Heart Failure Hospitalization in Patients with NYHA Class II Chronic Systolic Hert Failure
_ Sankyo Europe GmbH SE-505/14 Atherosclerosis n.a. Apres Juli 03 September 05 A Study of the new acat inhibitor CS-505 on the progression of atherosclwerosis as measured by 2-D and 3-D Caotid ultrasound (ACAT Inhibition Plaque Regression Stuy )
_ sanofi-aventis recherche et developpement n.a. Atrial Fibrillation AWB RecordAF Januar 08 Juni 08 Registry on Cardiac rhythm disorder: an international, observational, prospective survey assessing the control of Atrial Fibrillation
_ Solvay Pharmaceuticals S320.02.005 Contrast Media-induces Nephropathie II   April 07 April 09 A Mulitcenter, Feasibility Study to Evaluate Recruitment Rates for the double-blind, Randomized, Placebo-Controlled, Multicenter, Parallel-GroupStudy to Evaluate the Efects of SLV320 given intravenously on Top of Local Standard Care on Renal Function in Patients at High Risk for Contrast Media-Induces Nephropathy after Exposure to Intra-arterial Iso-or Low -osmolar Contrast Media