Home > Result Summaries: Compounds > rosiglitazone Result Summaries: rosiglitazone GSKStudy ID Phase Title Summary (Download) 100193 Phase 2 A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease (0 citation(s)) 100468 Phase 2 An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease (1 citation(s)) 100723 Phase 4 A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus (0 citation(s)) 101731 Phase 3 Interest of early combination with rosiglitazone in the optimized management of type 2 diabetic subjects poorly controlled with sulfonylurea or metformin monotherapy. OPTIMA study. (0 citation(s)) 101732 Phase 4 AVANTAGE: Monitoring a patient cohort treated with Avandia – Evaluation of safety data. (0 citation(s)) 104033 Phase 1 A 28-day, Randomised, Double-Blind, Active Comparator, Controlled Study to Assess the Effects of Rosiglitazone, Inhaled Corticosteroid, Theophylline and Theophylline Plus Inhaled Corticosteroid on Inflammation and Pulmonary Function in Asthmatic Smokers. (0 citation(s)) 104243 phase 1 An observational study to Assess the Impact of Pharmacological Intervention and Life Style Changes in the Reduction of Cardiovascular Disease in patients with diabetes type 2 in Greece (0 citation(s)) 104385 Phase 1 A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo. (0 citation(s)) 104670 phase 4 Adherence to Avandaryl Gycemic Control, Medical Resource Utilization and Costs (1 citation(s)) 105640 phase 3 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1) (1 citation(s)) 110825 Phase 1 A Single Center, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of XXX investigational drug on Hepatic Cytochrome P450 Activity in Healthy Adult Subjects (0 citation(s)) 111261 phase 4 Impact of ADA Treatment Guidelines for Type 2 Diabetes on Adherence and Economic Outcomes: Avandia plus Metformin therapy vs. Sulfonylurea plus Metformin therapy among Persistent Patients (1 citation(s)) 111262 phase 4 Resource utilization and costs associated with use of rosiglitazone versus insulin as add-on therapy to metformin users in the Veterans Administration (1 citation(s)) 111960 phase 4 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 People With Type 2 Diabetes at Risk For Cardiovascular Disease (1 citation(s)) 112611 phase 4 Prescription Patterns, Resource Utilization & Costs - Add-on Therapy with Anti Dipeptidyl Peptidase-IVs vs rosiglitazone (0 citation(s)) 112684 phase 1 Validation Study of Simultaneous Administration of Multiple Cytochrome P450/Transporter Probes for Drug Interaction Evaluation in Healthy Adult Subjects (0 citation(s)) 113017 Phase 4 2008 Update to Integrated Clinical Trial (ICT - also known as CV modeling) analysis for AVANDIA® (rosiglitazone maleate). (0 citation(s)) 113332 n\a The association between exposure to spironolactone or amiloride and fracture risk among subjects treated with thiazolidinediones (0 citation(s)) 113489 N/ An assessment of the Independent effect of oral antidiabetic agents and insulin exposure on the risk of myocardial infarction in type 2 diabetic patients (1 citation(s)) 113492 N/ Balanced cohort study of thiazolidinediones (TZDs) and other antidiabetic therapies and coronary heart disease events (1 citation(s)) 113497 n\a Reports of neoplasms in rosiglitazone clinical trials (0 citation(s)) 113505 N/ Coronary heart disease outcomes in patients receiving antidiabetic therapy (1 citation(s)) 113505_1 n\a Thiazolidinediones and coronary heart disease in a US health insurance database (1 citation(s)) 113639 n\a PEM study on Avandia use (0 citation(s)) 113985 N/A AVANDIA® (rosiglitazone maleate) 2009 Update to Integrated Cardiovascular (CV) Endpoint data from the Final Analyses for Studies BRL-049653/048 (ADOPT), AVD107642 (DREAM), and BRL-049653/231 (RECORD). (0 citation(s)) 114769 n\a A Meta Analysis of malignancy serious adverse events in the ADOPT, 49653/048, and RECORD, 49653/231, studies, comparing metformin with rosiglitazone. (1 citation(s)) 115170 phase 4 Blinded, Re-adjudication of Mortality and Major Cardiovascular Endpoints (MACE) from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of glycaemia in Diabetes trial (RECORD) (0 citation(s)) 116276 n\a Utilization of Rosiglitazone in Triple Therapy and Insulin Combinations, and Estimated Rates of Adverse Events in Rosiglitazone Recipients in Canada, 2004-2010 (0 citation(s)) 49563/145 Phase 3 A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Gliclazide Compared to Normal Upward Titration of Gliclazide in Patients with Type 2 Diabetes Mellitus. (2 citation(s)) 49653.347 Phase 4 A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin. (1 citation(s)) 49653/001 Phase 1 Evaluation of the Safety, Tolerablity and Preliminary Pharmacokinetics of Single Rising Doses of BRL 49653C in Normal Volunteers (0 citation(s)) 49653/002 Phase 1 An Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BRL 49653 after 10 Days Repeat Dosing to Obese Subjects (0 citation(s)) 49653/004 Phase 1 Investigation of the Effect of Food on the Pharmacokinetics of BRL 49653C in Healthy Male Volunteers (2 citation(s)) 49653/005 Phase 1 A Single Dose Study to Assess the Safety, Tolerability, Dose Proportionality and Food Effect of the Proposed Commercial Tablet Formulation of BRL 49653C in Healthy Volunteers (0 citation(s)) 49653/006 Phase 2 A 12-Week, Multicenter, Double-Blind, Placebo-Controlled, Dose Response Study Assessing the Safety, Tolerability, and Efficacy of BRL 49653C in Subjects with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (5 citation(s)) 49653/007 Phase 1 An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Hemodialysis-Dependent Patients with End Stage Renal Disease Compared to Volunteers with Normal Renal Function (4 citation(s)) 49653/008 Phase 1 An Evaluation of the Safety, Tolerability, Pharmacokinetics and Protein Binding of BRL 49653C in Patients with Hepatic Impairment (3 citation(s)) 49653/009 Phase 3 A Multicentre, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone When Administered to Patients With Type 2 Diabetes Mellitus. (0 citation(s)) 49653/011 Phase 3 A 26-Week Randomized, Double-blind, Multicenter, Placebo-Controlled, Comparison Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy when Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) (20 citation(s)) 49653/013 Phase 1 A Study of the Effect of Age on the Pharmacokinetics of BRL 49653C in Healthy Volunteers. (1 citation(s)) 49653/014 Phase 1 A Study to Determine the Effect of BRL 49653C on Steady-State Pharmacodynamics and Pharmacokinetics of Glyburide in Non-Insulin Dependent Diabetic Patients (0 citation(s)) 49653/015 Phase 3 A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Sulphonylurea therapy, When Administered to Patients with Type 2 Diabetes Mellitus. (7 citation(s)) 49653/016 Phase 1 Evaluation of the Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5, 10, 15 and 20 mg BRL 49653C in Healthy Male Volunteers (0 citation(s)) 49653/017 Phase 1 A Placebo-Controlled Single-Blind Study on the Safety, Tolerance and Pharmacokinetics of BRL49653C 1 mg, 2 mg, 4 mg, 8 mg and 16 mg in Single Oral Administration in Healthy Volunteers (0 citation(s)) 49653/018 Phase 1 Phase I Clinical investigation of 49653 (Series 2): A study on the effect of a Meal on the Pharmacokinetics of 49653 4 mg Administered Orally to Healthy Adult Volunteers (0 citation(s)) 49653/019 Phase 1 A Placebo-controlled Single-blind Study on the Safety, Tolerance and Pharmacokinetics of Single and 7-day (t.i.d.) Repeat Oral Administration of 49653 2mg in Healthy Adult Volunteers (0 citation(s)) 49653/020 Phase 3 A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide Therapy, When Administered to Patients with Type 2 Diabetes Mellitus. (14 citation(s)) 49653/022 Phase 2 A Double-Blind, Parallel Group Placebo-Controlled Study to Determine the Effects of Rosiglitazone on Insulin Resistance and Glucose Tolerance When Administered to Subjects with Impaired Glucose Tolerance. (4 citation(s)) 49653/024 Phase 3 A 26-week Randomized, Double-blind, Multicenter, Placebo-Controlled, Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy When Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) Using a Once Daily Dosing Regimen, and to Determine the Therap ... (11 citation(s)) 49653/025 Phase 3 A Multicentre, Double-Blind, Parallel Group Study to Determine the Effects of Rosiglitazone on Insulin Sensitivity, Endothelial Function and Vascular Reactivity in Comparison With Metformin and Placebo When Administered to Patients With Non-insulin Dependent Diabetes Mellitus. (2 citation(s)) 49653/028 Phase 1 Bioequivalence Study of the Final Market Formulation of BRL 49653C Compared to the Clinical Trials Formulation (0 citation(s)) 49653/029 Phase 1 Evaluation of the Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Intravenous Doses of BRL 49653C in Normal Volunteers (0 citation(s)) 49653/030 Phase 1 A Bioequivalence Study of BRL 49653C Proposed Final Market Tablet Formulation (formula AGAA) versus BRL 49653C Clinical Trials Capsule Formulation (formula AB-AA) (0 citation(s)) 49653/031 Phase 1 An Investigation of the Effect of BRL 49653C on the Safety, Tolerability and Pharmacokinetics of Oral Contraceptives in Healthy Female Volunteers (3 citation(s)) 49653/033 Phase 1 Placebo controlled, double-blind, trial to study the effect of 12 week treatment with BRL-49653C on glucose and insulin metabolism in obese patients with NIDDM (1 citation(s)) 49653/034 Phase 1 A Study to Assess the Effects of BRL 49653C on the Pharmacokinetics of Digoxin in Healthy Adult Males (6 citation(s)) 49653/035 Phase 1 A Study to Assess The Effect of BRL 49653C on the Anticoagulant Effect of Warfarin in Healthy Male Volunteers (0 citation(s)) 49653/036 Phase 1 A Study to Determine the Effect of BRL 49653C on the Pharmacokinetics of Metformin in Healthy Male Volunteers (2 citation(s)) 49653/037 Phase 1 A Study to Assess the Effect of Ranitidine on the Bioavailability of BRL 49653C in Healthy Adult Males (3 citation(s)) 49653/038 Phase 1 An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Patients with Varying Degrees of Renal Insufficiency Compared to Volunteers with Normal Renal Function (5 citation(s)) 49653/039 Phase 1 An Investigation of the Effect of BRL 49653C on the Safety, Tolerability and Pharmacokinetics of Nifedipine in Healthy Volunteers (2 citation(s)) 49653/040 Phase 1 Effect of Acarbose on the Pharmacokinetics of BRL 49653C in Healthy Adult Volunteers (3 citation(s)) 49653/041 Phase 1 A Study to Evaluate the Effect of Ethanol Administration on the Pharmacodynamics of BRL 49653C in Chronically-Treated Type 2 Diabetic Patients (2 citation(s)) 49653/043 Phase 1 Placebo-controlled, Double-Blinded Trial to Study the Absorptive and Post-Absorptive Skeletal Muscle and Hepatic Metabolic Effects of BRL-49653C After 12 weeks Treatment in Patients with Non-Insulin Dependent Diabetes Mellitus (0 citation(s)) 49653/044 Phase 3 A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BRL 49653C When Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Who Are Inadequately… (7 citation(s)) 49653/048 phase 3 A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients with Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus (5 citation(s)) 49653/049 Phase 1 A Study to Determine the Balance/Excretion, Pharmacokinetics and Biotransformation of BRL 49653 Given as a Single Oral (8 mg pfb) and Single Intravenous (2 mg pfb) Doses of [14C]-BRL 49653C to Healthy Male Adult Volunteers and Determine the Pharmacokinetics of a Single Oral Dose (2 x 4 mg Tablet ... (0 citation(s)) 49653/050 Phase 2 A Clinical Evaluation of BRL49653C in Type-2 Diabetes Mellitus; An Early Phase II Open-label Study (Monotherapy) (0 citation(s)) 49653/051 Phase 2 A Clinical Evaluation of BRL49653C in Non-insulin-dependent Diabetes Mellitus. (0 citation(s)) 49653/054 Phase 2 Clinical Evaluation of BRL49653C in Type-2 Diabetes Mellitus (Monotherapy) - Double-blind Dose-finding Study. (0 citation(s)) 49653/055 Phase 2 Clinical Evaluation of BRL49653C in Type-2 Diabetes Mellitus (Combination Therapy with Sulphonylurea) - Double-blind Dose-finding Study. (1 citation(s)) 49653/078 Phase 1 A Placebo-controlled Study to Evaluate the Effect of Rosiglitazone on Plasma Volume and Red Blood Cell Volume in Healthy Volunteers (0 citation(s)) 49653/079 Phase 3 A 26-week Randomized, Double-Blind, Double-Dummy, Multicentered Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maximal Dose (20 mg/day) of Glyburide. (0 citation(s)) 49653/080 Phase 3 A 3 Year Open-label, Multicenter, Active (Glyburide) Comparison Study to Evaluate the Effect of Rosiglitazone on Cardiovascular Function in Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) (12 citation(s)) 49653/082 Phase 3 A 26-Week Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL 49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy (4 citation(s)) 49653/083 Phase 3 Investigation of the effects of the thiazolidinedione, rosiglitazone, on regional adiposity, intrahepatic fat and muscle insulin sensitivity in type 2 diabetic patients (TRIM) (7 citation(s)) 49653/084 Phase 3 An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of BRL 49653C when Administered as Monotherapy, Twice Daily, to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (0 citation(s)) 49653/085 Phase 3 A 26 Week Randomised, Double-Blind, Multicentre Study to Investigate the Effects of Rosiglitazone on Insulin Requirements in Insulin-Treated Type 2 Diabetic Patients (0 citation(s)) 49653/087 Phase 1 A Placebo-controlled Single-blind Study on the Safety, Tolerance and Pharmacokinetics of Single and 7-day (b.i.d.) Repeat Oral Administration of BRL49653C 4mg in Healthy Adult Volunteers. (0 citation(s)) 49653/090 Phase 3 An 8-week Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Rosiglitazone (BRL 49653) Therapy when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Using a Twice Daily D ... (3 citation(s)) 49653/091 Phase 3 A Multicentre, Open Label Extension Study To Assess the Long Term Safety, Tolerability and Efficacy of Rosiglitazone when Administered as Monotherapy, Once Daily to Patients with Type 2 Diabetes Mellitus (0 citation(s)) 49653/093 Phase 3 A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone 4mg twice daily when Administered to Subjects with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5mg/d ... (3 citation(s)) 49653/094 Phase 3 A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5 mg/day) ... (8 citation(s)) 49653/095 Phase 3 A 26-week Randomised, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Type 2 Diabetes who are Inadequately Controlled on Insulin Monotherapy (0 citation(s)) 49653/096 Phase 3 A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on… (0 citation(s)) 49653/097 Phase 3 A 3-Year Open-Label, Multicenter, Active (Glyburide) Comparison Study, to Evaluate the Effect of BRL 49653C 8mg od on Cardiovascular Function in Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (0 citation(s)) 49653/098 Phase 2 A Multicentre, Double-Blind, Parallel Group, Placebo-Controlled Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily to Patients with Type 2 Diabetes Mellitus (6 citation(s)) 49653/101 Phase 1 A placebo controlled single-blind study on the safety, tolerance and pharmacokinetics of single and 8-day (u.i.d) repeat oral administration of BRL 49653C 8 mg in healthy adult volunteers (0 citation(s)) 49653/105 Phase 3 An Open-label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of BRL 49653C When Administered as Monotherapy, Once Daily, to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (0 citation(s)) 49653/108 Phase 3 A 16-Week Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Hypolipidemic Therapy with an HMGCoA Reductase Inhibitor (Atorvastatin) in Type 2 Diabetes Mellitus Patients Treated with Rosiglitazone (BRL 49653C) 4mg bd (9 citation(s)) 49653/109 Phase 3 An Open-label, Positive-controlled, Parallel-group Study to Determine the Effect of BRL 49653C, Rosiglitazone, on Body Fat Distribution When Administered for 26 Weeks to Patients with Type 2 Diabetes (1 citation(s)) 49653/112 Phase 3 An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone When Administered Once or Twice Daily in Combination with Glyburide to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (0 citation(s)) 49653/113 Phase 3 An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of 49653 When Administered Once or Twice Daily in Combination with Metformin to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (2 citation(s)) 49653/114 Phase 3 An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone When Administered Once or Twice Daily in Combination with Insulin to Patients with Type 2 Diabetes (0 citation(s)) 49653/116 Phase 1 An Investigation of the Effect of Rosiglitazone Maleate (BRL 49653C) Versus Troglitazone on the Safety, Tolerability and Pharmacokinetics of Triazolam in Healthy Volunteers (0 citation(s)) 49653/117 Phase 1 A Study to Evaluate the Relative Bioavailability of Two Enterically-Coated Formulations of Rosiglitazone Compared to the Immediate Release Formulation of Rosiglitazone in Healthy Volunteers. (0 citation(s)) 49653/121 Phase 1 An Investigation of the Pharmacokinetics of Single 4 mg and Repeat 4 mg Twice Daily and Single and Repeat 8 mg Once Daily Doses of Rosiglitazone in Healthy Volunteers (0 citation(s)) 49653/125 Phase 3 An Open-Label Study to Assess the Efficacy and Safety of Rosiglitazone with Concurrent Sulphonylurea Therapy when Administered to Subjects with Type 2 Diabetes (2 citation(s)) 49653/127 Phase 3 A 26-Week Randomized, Double-Blind Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone 8mg/day (4mg bd) Versus Placebo in Combination with Glyburide in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide (6 citation(s)) 49653/128 Phase 3 A double-blind, multicenter, placebo controlled, parallel group comparative study to evaluate the efficacy and safety of BRL 49653C (Avandia) with concurrent sulphonylurea therapy, when administered to patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) (0 citation(s)) 49653/129 Phase 1 An Evaluation of the Safety and Tolerability of Single Rising Doses of Rosiglitazone in Healthy Chinese male Subjects. (0 citation(s)) 49653/130 Phase 1 An Evaluation of the Safety, Tolerability and Pharmacokinetics of Rosiglitazone after 8 Days Repeat –Dosing to Healthy Chinese Subjects. (0 citation(s)) 49653/131 Phase 3 A Double-blind, Placebo-controlled, Parallel-group Study to Determine the Effect of BRL- 49653C Rosiglitazone, on Fat Distribution When Administered for 26 Weeks to Subjects With Impaired Glucose Tolerance (IGT) (1 citation(s)) 49653/132 Phase 2 A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Assess the Efficacy and Safety of Rosiglitazone with Concurrent Sulphonylurea Therapy when Administered to Subjects with Non-Insulin-Dependent Diabetes Mellitus (Type 2 Diabetes) (4 citation(s)) 49653/133 Phase 3 An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone (BRL 49653C) When Administered Twice Daily in Combination with Glyburide to Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide (from study 49653-127) (0 citation(s)) 49653/134 Phase 3 A 26-Week Randomized, Double-Blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone (2 mg BID and 4 mg BID) Versus Placebo in Combination with Glyburide and Metformin in Patients with Type 2 Diabetes Mellitus (1 citation(s)) 49653/135 Phase 3 2-year, Randomized, Double-blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glipizide Therapy (3 citation(s)) 49653/136 Phase 3 A 26-week Randomised, Double-Blind, Multicentre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Insulin Therapy and/or a Sulphonylurea in Type 2 Diabetic Patients with Chronic Renal Failure (Not on Dialysis). (0 citation(s)) 49653/140 Phase 3 A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Effects of Rosiglitazone on Post Prandial Glycaemia in Type 2 Diabetic Patients. (5 citation(s)) 49653/142 Phase 1 An evaluation of the Pharmacokinetics of Single Dose of Rosiglitazone in Healthy Chinese Male Subjects. (0 citation(s)) 49653/143 Phase 4 A 24-Week Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of AVANDIA (8mg once daily) in Combination with Glyburide in African American and Hispanic Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glyburide Monotherapy (2 citation(s)) 49653/147 Phase 3 A multicentre, double-blind, placebo-controlled, parallel group, comparative study to evaluate the efficacy, safety and tolerability of rosiglitazone with concomitant oral therapy with sulphonylurea when administered for 26 weeks to patients withtype 2 diabetes and who are… (2 citation(s)) 49653/151 Phase 2 Clinical Evaluation of BRL49653C (BID) in Type-2 Diabetes Mellitus (Monotherapy) – Double-blind, dose response study. (0 citation(s)) 49653/152 Phase 3 A multicentre, open-label study (26 weeks) to evaluate the efficacy and tolerability of rosiglitazone when administered to patients with type 2 diabetes who are inadequately controlled with diet either alone or together with oral antidiabetic therapy (0 citation(s)) 49653/154 Phase 3 A multicentre, open label, comparative study to evaluate the efficacy, safety and tolerability of rosiglitazone + metformin vs glibencamide + metformin (fixed combination) in type 2 diabetic subjects fairly controlled on up to half maximal dose of monotherapy drugs and requiring tighter metaboli ... (0 citation(s)) 49653/157 Phase 3 A multicentre, double-blind, randomised, parallel-group study of 26 weeks duration to assess the efficacy, safety and tolerability of Rosiglitazone compared to Acarbose in the treatment of Non-insulin dependent Diabetes Mellitus. (0 citation(s)) 49653/159 Phase 2 Clinical Evaluation of BRL49653C twice daily in Type-2 Diabetes Mellitus (Combination therapy) – Double-blind, dose-finding study. (0 citation(s)) 49653/160 Phase 2 Clinical Evaluation of BRL49653C (BID) in Non-Insulin Dependent Diabetes Mellitus (Monotherapy) -Extension Study. (0 citation(s)) 49653/161 Phase 1 An evaluation of the pharmacokinetics of single doses of Rosiglitazone in healthy Taiwanese male subjects (0 citation(s)) 49653/162 Phase 3 A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Glibenclamide Compared to Normal Upward Titration of Glibenclamide in Patients with Type 2 Diabetes Mellitus (4 citation(s)) 49653/163 Phase 1 A Single Dose Study to Assess the Safety, Tolerability and Bioequivalence of the 2 x 2 mg versus the 4 mg Commercial Tablet Formulations of Rosiglitazone in Healthy Male Japanese Volunteers (0 citation(s)) 49653/166 Phase 1 Evaluation of Safety and Pharmacokinetics of Single Dose of Rosiglitazone in Healthy Korean Male Volunteers (0 citation(s)) 49653/171 Phase 4 An open-label, non-comparative multi centre study to obtain further information on the efficacy and safety of rosiglitazone as monotherapy when administered to Asian patients with Type 2 Diabetes Mellitus. (0 citation(s)) 49653/177 Phase 4 AVA-177: Avandia in daily practice. (1 citation(s)) 49653/183 Phase 3 A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of Oral Formulation X and AVANDIA™ (4mg BD) in Patients with Type 2 Diabetes (0 citation(s)) 49653/185 Phase 4 Rosiglitazone Evaluation: Advancing Canadian Treatment of Type 2 Diabetes (REACT 2) (0 citation(s)) 49653/203 Phase 4 A post-marketing surveillance study of Avandia (Rosiglitazone) in the treatment of Filipino patients with type 2 diabetes (0 citation(s)) 49653/206 Phase 1 An open label, single center, randomized, cross-over study to determine the bioequivalence of the final market formulation of Rosiglitazone and the clinical trials formulation in Chinese subjects. (0 citation(s)) 49653/207 Phase 3 A 24-week Randomized, Double-blind, Active-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rosiglitazone When Administered to Pediatric Patients with Type 2 Diabetes Mellitus (1 citation(s)) 49653/210 Phase 3 An open-label, 16 weeks, non-comparative study to evaluate the efficacy and safety of Avandia (rosiglitazone) monotherapy, when administrated to patients with Type 2 Diabetes Mellitus (T2DM). (0 citation(s)) 49653/211 Phase 3 A 52-week double-blind study of the effect of rosiglitazone on cardiovascular structure and function in subjects with type 2 diabetes mellitus and congestive heart failure (NYHA class I/II) (2 citation(s)) 49653/224 Phase 1 A Study to Examine the Effects of Alucol® , a Combination Magnesium/Aluminum Hydroxide-Containing Antacid, on the Pharmacokinetics of Rosiglitazone (8 mg). (0 citation(s)) 49653/225 Phase 1 A Double-Blind Study to Assess the Effect of Rosiglitazone (RSG) on the Pharmacodynamics and Pharmacokinetics of Acenocoumerol in Healthy Male Volunteers (0 citation(s)) 49653/234 Phase 3 A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Rosiglitazone in Combination with Glimepiride compared to Glimepiride Alone in Patients with Type 2 Diabetes Mellitus. (2 citation(s)) 49653/267 Phase 4 A multi-center, open-label study to assess the safety and efficacy of rosiglitazone (RSG) as monotherapy or in combination therapy with concurrent Metformin (Met) or Sulphonylurea (SU) when administered to Chinese patients with Type 2 diabetes. (1 citation(s)) 49653/267_1 Phase 4 A multi-center, open-label extension study to assess the safety and efficacy of rosiglitazone as monotherapy or in combination with concurrent metformin or sulphonylurea therapy when administered to patients with type 2 diabetes. (0 citation(s)) 49653/270 Phase 1 A Bioequivalence Study With a Combination Tablet Formulation of Rosiglitazone and Metformin (4 mg/500 mg) Compared to Concomitant Dosing of Rosiglitazone 4 mg and Metformin 500 mg Commercial Tablets-and a Dose Proportionality Study Comparing the 4 mg/500 mg and 1 mg/500 mg Combination Formulations. (0 citation(s)) 49653/271 Phase 1 A Study to Assess the Effect of Food on the Pharmacokinetics of a Rosiglitazone 4 mg and Metformin 500 mg Combination Tablet Formulation and a Study Comparing the Pharmacokinetics of Rosiglitazone 4 mg and Metformin 500 mg Combination Tablet to Concomitant Dosing of Rosiglitazone 4 mg and Metfor ... (0 citation(s)) 49653/282 Phase 4 A Double-Blind Feasibility Study to Estimate and Compare the Effect of Rosiglitazone in Parallel with Glyburide on Cognition in Patients with Type 2 Diabetes Mellitus (2 citation(s)) 49653/284 Phase 4 A 24-Week Randomized, Double-blind, Double-Dummy, Multicenter Study to Compare the Efficacy of AVANDIA when added to Submaximal Doses of Metformin and to Compare the Tolerability of the Combination to Metformin Monotherapy when Administered to Subjects with Type 2 Diabetes Mellitus (3 citation(s)) 49653/292 Phase 2 A Randomized, Double-Blind, Placebo-Controlled Trial to Assess Three Dose Levels of Rosiglitazone Maleate in the Treatment of Moderate to Severe Plaque Psoriasis. (0 citation(s)) 49653/295 Phase 4 AVA-295: Avandia in daily practice. (1 citation(s)) 49653/299 Phase 1 A single dose study to assess the tolerability and food effect of an enterically-coated formulation of the commercial immediate release tablet of rosiglitazone and an enterically-coated modified release tablet formulation of rosiglitazone in healthy volunteers. (0 citation(s)) 49653/300 Phase 1 A Bioequivalence Study Comparing Tablets Manufactured with the 8 mg Anhydrate Form IV (ANF4) to the Commercial Anhydrate Form I (ANF1) of Rosiglitazone Maleate. (0 citation(s)) 49653/301 Phase 1 A Study to Evaluate the Effect of Food on the Pharmacokinetics of a Modified Release Formulation of Rosiglitazone 8 mg in Healthy Volunteers After Repeat Dosing. (0 citation(s)) 49653/309 Phase 1 A study to evaluate the pharmacokinetics of eight prototype formulations of rosiglitazone 8 mg in healthy volunteers. (0 citation(s)) 49653/311 Phase 4 A 12-Week, Randomized, Double-blind Study to Evaluate the Effects of Rosiglitazone 4 mg BD and Rosiglitazone 4 mg QD on Lipids in Type 2 Diabetes Mellitus Subjects Taking Statins (2 citation(s)) 49653/325 Phase 3 A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Rosiglitazone in Combination with Glimepiride Compared to Glimepiride Plus Placebo for 24 Weeks in Subjects with Type 2 DiabetesMellitus Who are Inadequately Controlled on Non-TZD Oral Monotherapy (1 citation(s)) 49653/326 Phase 4 A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients with Type 2 Diabetes Mellitus (2 citation(s)) 49653/329 Phase 4 AVA-329: Avandia in daily practice. (0 citation(s)) 49653/330 Phase 3 A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Three Dose Levels of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis (0 citation(s)) 49653/331 Phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis (1 citation(s)) 49653/334 Phase 4 See Detailed Description (1 citation(s)) 49653/339 Phase 1 A Study to Investigate the Mechanism of Fluid Retention with AVANDIA™ in Combination with a Euglycaemic/Hyperinsulinaemic Clamp. (0 citation(s)) 49653/340 Phase 1 A Study to Estimate the Effect of Repeat Oral Doses of Rosiglitazone (8 mg) on the Pharmacokinetics of Glimepiride (4 mg) and the Effect of a Single Oral Dose of Glimepiride (4 mg) on the Pharmacokinetics of Rosiglitazone (8 mg) in Healthy Subjects. (0 citation(s)) 49653/342 phase 4 See Detailed Description (2 citation(s)) 49653/347 phase 4 A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled on Insulin (1 citation(s)) 49653/349 Phase 4 A 52-week pharmacovigilance study to assess the safety of oral prescription medicine AVANDIA™ (rosiglitazone) 4mg and 8mg daily in conjunction with sulfonylurea or metformin, in patients with type-2 diabetes mellitus. (0 citation(s)) 49653/351 Phase 4 Rosiglitazone and Plaque Study: A 12 Month Randomised, Double-blind, Placebo-controlled, Magnetic Resonance Imaging Study to Evaluate the Effect of Rosiglitazone on the Structure and Composition of Carotid Atherosclerotic Plaques in Subjects with Type 2 Diabetes Mellitus and Coexisting Vascular ... (0 citation(s)) 49653/352 Phase 3 A 16 Week Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effect of Rosiglitazone on Myocardial Glucose Uptake in Subjects with Type 2 Diabetes Mellitus and Stable Coronary Heart Disease (2 citation(s)) 49653/362 Phase 4 A 12-Week Randomized, Double-Blind, Local Multicenter, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Rosiglitazone (BRL 49653C) When Administered Once Daily To Patients With Type-2 Diabetes Mellitus (T2DM) Who Are Inadequately Controlled On At Least Half Maximal D ... (0 citation(s)) 49653/369 Phase 4 A six-month double-blind, randomised, parallel-group study to compare the effect of oral rosiglitazone (less than or equal to 4mg bd) versus oral glibenclamide therapy (less than or equal to 15mg daily) on body fat distribution when administered to subjects with type 2 diabetes mellitus (0 citation(s)) 49653/371 Phase 4 Influence of guideline-compliant treatment of diabetes mellitus type 2 on effectiveness and costs (LEADIT/ADIT) (2 citation(s)) 49653/374 Phase 3 Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (0 citation(s)) 49653/375 Phase 3 A single-centre, randomised, double-blind, placebo controlled, two 12 week period, cross-over phase III study to investigate the effect of rosiglitazone 4mg bd on the vasodilator response to hyperinsulinaemia in obese insulin resistant subjects. (3 citation(s)) 49653/376 Phase 3 A 16-week, randomised, double-blind, placebo-controlled, single-centre study to investigate fluid retention in insulin-treated subjects with type 2 diabetes mellitus and varying degrees of autonomic neuropathy when administered rosiglitazone 4 mg bd (1 citation(s)) 49653/390 Phase 4 An Open-label study to assess the efficacy and safety of rosiglitazone with concurrent sulphonylurea therapy when administered to subjects with type 2 diabetes mellitus. (0 citation(s)) 49653/393 Phase 4 A 26-week Open Label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maximum Dose of Metformin (2.5 g/day) or… (0 citation(s)) 49653/398 Phase 1 A study to evaluate the pharmacokinetics of six prototype formulations of rosiglitazone 8 mg in healthy volunteers after repeat dosing. (0 citation(s)) 49653/411 Phase 1 A Study to Evaluate the Effect of Single and Repeat Doses of Rosiglitazone on the Pharmacokinetics of Methotrexate in Patients Receiving Methotrexate for Psoriasis (0 citation(s)) 49653/413 Phase 1 A study to evaluate the effect of repeat doses of rosiglitazone on the pharmacokinetics of repeat doses of acitretin in patients receiving acitretin for psoriasis. (0 citation(s)) 49653/414 Phase 1 An open-label, non-randomized, two period study to investigate the pharmacokinetics of rosiglitazone and glibenclamide when administered alone and concomitantly in healthy male Japanese and Caucasian subjects. (0 citation(s)) 49653/423 Phase 3 An Open-Label Study to Obtain Clinical Experience with BRL49653C with Concurrent Alpha-glucosidase Therapy in Patients with Type 2 Diabetes Mellitus (0 citation(s)) 49653/432 Phase 4 A 24-week Open-Label, Multicenter, Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered to Subjects with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (1.5 to 2.5 g/day) of Metformin. (0 citation(s)) 49653/439 phase 4 A 2 years pharmacovigilance study to assess the safety of oral prescription medicine AVANDIA 4mg and 8 mg daily in conjunction with sulfonylurea or metformin , in patients with type-2 diabetes mellitus. (0 citation(s)) 49653/452 Phase 2 A randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability and efficacy of six months' administration of AVANDIA (rosiglitazone maleate) in subjects with Relapsing-Remitting Multiple Sclerosis (MS) (0 citation(s)) 49653/454 Phase 4 A Single-blind, Randomised, Positive-controlled, Parallel-group Multicentre Study to Compare the Effect of Glibenclamide plus Rosiglitazone vs Glibenclamide plus Placebo on Body Fat Distribution When Administered for 12 Months to Korean Patients with Type 2 Diabetes Mellitus. (0 citation(s)) 49653/902 Phase 1 An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosiglitazone when Co-administered with Gemfibrozil in Healthy Adult Subjects (0 citation(s)) 49653/903 Phase 1 A randomized, open-label, two-period crossover study to demonstrate the bioequivalence of twice-daily immediate release and once-daily extended release rosiglitazone dosing over five days in healthy volunteers. (0 citation(s)) 999910/150 Phase 2 A study in patients with Crohn's Disease to evaluate the effect of AVANDIA™ on inflammatory activity mediated by monocytes/macrophages. (0 citation(s)) 999910/189 Phase 1 A comparison of the effects of AVANDIA® on arterial stiffness in obese subjects and healthy non-obese control subjects (0 citation(s)) 999910/196 Phase 1 A randomized, placebo-controlled, single blind, 4 way cross-over study to investigate the effects of a single dose of Avandia® on renal function in healthy male volunteers. (0 citation(s)) ARA102198 phase 2 A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis (0 citation(s)) AVA102670 phase 3 A 54-week, study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease (REFLECT-3) (1 citation(s)) AVA102672 phase 3 A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease. (1 citation(s)) AVA102675 phase 3 An open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimers disease (REFLECT-4). (1 citation(s)) AVA102677 phase 3 An open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) in subjects with mild-to-moderate Alzheimer's disease (REFLECT-5) (1 citation(s)) AVA104617 phase 2 An open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease (0 citation(s)) AVALON Phase 4 Avandia Longitudinal Observational Network (AVALON) (0 citation(s)) AVD100521 phase 3 A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone versus Glipizide on the Progression of Atherosclerosis in Subjects with Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH) (4 citation(s)) AVD102209 phase 3 A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin (0 citation(s)) AVD104742 phase 3 Clinical evaluation of Rosiglitazone Malate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo - (2 citation(s)) AVD105248 Phase 3 Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Combination Therapy with SU) - A Placebo-Controlled Double-Blind Study - (0 citation(s)) AVD105720 Phase 3 Clinical evaluation of Rosiglitazone Malate (BRL49653C) in patients with type 2 diabetes mellitus -Long-term study of Rosiglitazone Maleate- (0 citation(s)) AVD111179 phase 4 A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study with a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women with Type 2 Diabetes Mellitus (1 citation(s)) BRL-049653/231 phase 3 A long term, open label, randomised study in patients with type 2 diabetes, comparing the combination of rosiglitazone and either metformin or sulfonylurea with metformin plus sulfonylurea on cardiovascular endpoints and glycaemia (5 citation(s)) BRL-49653/137 Phase 3 A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects with Type 2 Diabetes Mellitus (2 citation(s)) BRL-49653/461 phase 2 A double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) on cerebral glucose utilization and cognition in subjects with mild to moderate Alzheimer's Disease (AD) (0 citation(s)) DIX110434 phase 1 See Detailed Description (1 citation(s)) RES11098 Phase 1 A Randomized, Single-Blind, Placebo-Controlled, Parallel Group, Exploratory Research Study to Describe the Pharmacodynamic Effects of Glyburide, Metformin, and Rosiglitazone versus Placebo for 8 Weeks in Adult Subjects with Type 2 Diabetes Mellitus (0 citation(s)) RO12003 Phase 4 Efficacy and Safety of Rosiglitazone in the Treatment of Type 2 Diabetes Mellitus (0 citation(s)) ZM2005/00181/01 N/A Avandia Cardiovascular Event Modeling Project (1 citation(s)) ZM2005/00181/01 and HM2006/00497/00 Phase 3 "Study No.: ZM2005/0018/01: Avandia Cardiovascular Event Modeling Project (0 citation(s))
