Clinical Study Protocol Summaries

A Japanese translation of the following summary is also available; however, the Japanese version discusses clinical trials in Japan only.

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All Clinical Study Protocol Summaries

VN01/12	Evaluation of Efficacy and Safety of the fixed-dose combination of Coumarin and Troxerutin (Venalot®) versus Placebo in the Symptomatic Treatment of Chronic Venous Insufficiency.
SYR-472/OCT-002	SYR-472 Open-label Study
TAK-875_310	A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes
TAK-875_309	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Placebo as an Add-on to Glimepiride in Subjects With Type 2 Diabetes
TAK-875_303	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared to Placebo When Used in Combination with Sitagliptin in Subjects with Type 2 Diabetes
VT-4001-001-SP	VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.
ROF-ASTHMA-202	A Phase 2, Randomized, Double-blind, 4-week Cross-over Trial to Investigate The Effect of a Once-daily Combination of Roflumilast Plus Montelukast Versus Montelukast Alone on Pulmonary Function, Asthma Symptoms and Inflammatory Markers in Subjects With Severe Asthma Not Adequately Controlled With a Combination of at Least Medium Dose Inhaled Corticosteroids and Long-acting Beta Agonists Maintenance Therapy.
CCR-FEB-002	The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Subjects With Chronic Stable Angina: A Phase 4 Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study
RO-2455-405-RD	Effect of Roflumilast 500 μg Tablets Once Daily at Acute COPD Exacerbations Treated With Standard Therapy of Oral Steroids and Antibiotics. A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial
BY9010/CH-101	Ciclesonide For The Treatment Of Airway Hyper-Responsiveness: The Mannitol Asthma Ciclesonide Study (Macs)  A Double-Blind, Randomized, Parallel Group Study
MV-9999-301-RU	Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREPR® Bowel Preparation Prior to Colonoscopy
ROF-NASH_205	A Randomized, Double-Blind, Controlled, Multi-Center Phase 2 Study to Evaluate the Effect of Roflumilast Plus Pioglitazone on Liver Enzymes and Liver Fat Content in Subjects With Nonalcoholic SteatoHepatitis
TAK-536TCH	PhaseII/III double-blind comparative study of the efficacy and safety of TAK-536CCB when coadministered with hydrochlorothiazide in patients with grade I or II essential hypertension PDF 0.1MB 2P
TAK-375SL_302	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar 1 Disorder in Adult Subjects
TAK-375SL_301	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects
ROF-T2D_107	A Phase 1b, Randomized, Double-Blind, Active Comparator (Open-Label Exenatide) Controlled Study to Evaluate the Effect of Roflumilast Plus Alogliptin on Postprandial Active GLP-1 Level and 24-hour Glucose Level in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on a Stable Dose of Metformin
TAK-875_307	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg Compared With Placebo in Asia Pacific Subjects With Type 2 Diabetes
TAK-390MR_207	A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years
TAK-390MR_206	A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
CW-2200-401-RD	A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PTH) as Measurements of Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men Compared to Baseline.
TAK-875_306	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events
LuAA21004_202	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD)
TAK-875_302	A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes
TMX-67_207	A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Exercise Tolerance in Subjects With Chronic Stable Angina
TAK-491_304	A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes
TAK-875_118	A Phase 1, Single-Blind, Placebo Controlled, Sequential Design Study to Evaluate the Drug Interaction Potential Between Glimepiride and TAK-875 in Subjects With Type 2 Diabetes Mellitus
TMX-67_206	A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension
TAK-875_304	A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Glimepiride When Used in Combination With Metformin in Subjects With Type 2 Diabetes
TAK-361S	A phase 2, Dose-finding Study of TAK-361S in Healthy Pediatric Subjects PDF 0.1MB 2P
TAK-536CCB	Phase III double-blind study of TAK-536CCB in patients with grade I or II essential hypertension PDF 0.1MB 2P

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