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

April 26, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 untreated hypertension, on or off background antihypertensive medications. This double-blind, placebo controlled study investigates the long-term efficacy of topiramate for reduction of weight and blood pressure in obese patients with mild-moderate hypertension, and the safety and tolerability of topiramate in this patient population. The study consists of 4 phases: 6 week run-in phase (2 weeks screening and 4 weeks single-blind placebo), 8 week titration phase (topiramate group will have their dose increased from 16mg/day to either 96mg/day or 192mg/day), 52 week maintenance phase (patients will receive fixed dose of either topiramate or placebo) and 6 week follow-up phase. Beginning at enrollment and throughout the study, all subjects participated in a standardized behavioral modification program which provides subjects with lifestyle and self-management strategies for diet, nutrition and physical activity. Effectiveness will be evaluated by multiple measurements such as change in body weight, sitting diastolic blood pressure, sitting systolic blood pressure, Body Mass Index, number and proportion of treatment responders, volume of left ventricle of the heart as measured by echocardiography, and fasting lipid profile. Safety evaluations (incidence and severity of adverse events, vital signs, 12 lead ECG, clinical laboratory results) will be conducted throughout the study. The study hypothesis is that topiramate is effective in reducing blood pressure in obese patients with mild to moderate hypertension and is well tolerated. During the initial 8 weeks, the dose of topiramate or placebo will be gradually increased to the target doses (either 48mg twice daily or 96mg twice daily by mouth) and the doses will be maintained for 52 weeks.

Study Type

Interventional

Enrollment (Actual)

531

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The percent change in body weight and in sitting diastolic blood pressure from baseline/randomization (Week 0) to Week 60.

Secondary Outcome Measures

Outcome Measure
Percent change in body weight (from enrollment only), absolute change in body weight, Body Mass Index, sitting systolic and diastolic blood pressure from enrollment and baseline to week 60; safety evaluations during the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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