Status:
TERMINATED
A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Hyperlipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 red...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00231621
Start Date
May 1 2001
End Date
June 1 2002
Last Update
June 8 2011
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