Study Stopped
The study was terminated prior to completion to focus on the development of a controlled release formulation.
A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
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
1 other identifier
interventional
179
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started May 2001
Shorter than P25 for phase_3 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedJune 8, 2011
April 1, 2010
September 30, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- A Body Mass Index (BMI) \>= 27 kg/m\^2 and \<50 kg/m\^2
- Stable weight at least four months prior to the first enrollment visit
- Diagnosis of dyslipidemia (serum triglycerides representative of mild to moderate hypertriglyceridemia and low HDL or high LDL)
- Patients on lipid lowering medication should be on monotherapy with the same drug for at least 4 months and on the same dose for at least 2 months prior to the first enrollment
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
You may not qualify if:
- Contraindication or hypersensitivity to topiramate
- Pregnancy, nursing or women who plan to become pregnant during the study
- Enrollment fasting triglycerides \<175 or \>= 1000 mg/dL, and/or LDL \>= 190 mg/dL
- Hyperlipidemia secondary to known disease
- Other significant medical conditions such as cardiovascular or liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
May 1, 2001
Study Completion
June 1, 2002
Last Updated
June 8, 2011
Record last verified: 2010-04