A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
The purpose of this study is to compare the efficacy and safety of daily topiramate versus placebo for the treatment of obese subjects with dyslipidemia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, One-year Study of the Efficacy and Safety of Topiramate in the Treatment of Obese Subjects With Dyslipidemia|
- Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.
- Absolute change in body weight, body mass index, triglycerides, and absolute and percentage changes in cholesterol measures from baseline to Week 60. Safety evaluations throughout study.
|Study Start Date:||May 2001|
|Study Completion Date:||June 2002|
Topiramate is not approved for the treatment of obesity. Studies have shown that topiramate reduces weight in obese patients with or without Type 2 diabetes, and may have the adjunctive benefit of reducing triglyceride and cholesterol levels in these patients. This double-blind, placebo controlled study evaluates the long-term efficacy of topiramate for reduction of weight and triglyceride levels in obese patients with borderline to high hypertriglyceridemia, and the safety and tolerability of topiramate in this patient population. The study consists of four phases: 4-week enrollment (screening) phase, 8-week titration phase (topiramate dose will be increased from 16mg/day to the assigned dose), 52-week maintenance phase, and 6-week follow-up. Effectiveness of topiramate will be evaluated by multiple measurements such as change in body weight, body mass index, fasting serum triglyceride levels, cholesterol and other lipid profiles. Safety evaluations will include incidence/severity of adverse events, vital signs, clinical laboratory results. The hypothesis is that topiramate as compared to placebo will provide a greater percent reduction in body weight and in fasting serum triglycerides from Week 0 (baseline) to Week 60. After the initial 8-weeks titration phase, the patients will be randomized to receive either 96mg (48mg twice daily) or 192mg (96mg twice daily) topiramate or placebo (twice daily) by mouth for 52 weeks.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|