Status:
COMPLETED
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study assesses long-term effectiveness and safety of topiramate in patients with obesity. After completin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
1293 Patients enrolled
Trial Details
Trial ID
NCT00236639
Start Date
July 1 2000
End Date
June 1 2002
Last Update
April 28 2010
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