Overview

A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Status:
Completed
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 topiramate (96, 192, and 256mg daily) with placebo in long-term treatment of obesity.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Topiramate
Criteria
Inclusion Criteria:

- Body Mass Index (BMI) >= 30 and < 50

- BMI >= 27 and < 50 if patient has controlled hypertension or abnormal blood lipids

- Stable weight

- 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:

- Known contraindication, or hypersensitivity to topiramate

- A diagnosis of diabetes (except those diagnosed during the enrollment if no
medications are needed)

- History or evidence of clinically significant liver, disease, cardiovascular disease,
uncontrolled hypertension or high thyroid levels

- History of obesity with known cause

- History of weight loss surgery or liposuction

- History of malignancy within last 5 years