A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia

• Status: Terminated
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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