Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231621
Status:
TERMINATED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated prior to completion to focus on the development of a controlled release formulation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 16mgday 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 incidenceseverity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None