Status:
COMPLETED
A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Hypertension
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 (96mg or 192mg) versus placebo in obese patients with mild to moderate high blood pressure.
Detailed Description
Topiramate is not approved for the treatment of obesity. The use of topiramate to reduce weight in obese patients may have the adjunctive benefit of reducing blood pressure in subjects with treated or...
Eligibility Criteria
Inclusion
- Diagnosis of mild to moderate essential hypertension (sitting diastolic blood pressure \>= 90 and \< 110 and/or sitting systolic blood pressure \>= 140 and \< 180)
- Diagnosis of obesity (Body Mass Index \>= 27 and \< 50 and steady body 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
- Prior exposure or known contraindication or hypersensitivity to topiramate
- Pregnancy, nursing or subjects who plan to become pregnant during the study
- Diagnosis of severe hypertension
- History or diagnosis of Diabetes Mellitus
- A history of diastolic or systolic hypertension secondary to a known cause
- Significant cardiovascular or liver disease
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT00236665
Start Date
March 1 2001
End Date
June 1 2002
Last Update
April 28 2010
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