A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension

• 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 daily topiramate (96mg or 192mg) versus placebo in obese patients with mild to moderate high blood pressure.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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