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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236665
First received: October 7, 2005
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Obesity
Hypertension
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 531
Study Start Date: March 2001
Study Completion Date: June 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236665

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00236665     History of Changes
Other Study ID Numbers: CR003727
Study First Received: October 7, 2005
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Obesity
Essential Hypertension
Mild Hypertension
Moderate Hypertension
High Blood Pressure

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 23, 2014