A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension
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
1 other identifier
interventional
531
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Mar 2001
Shorter than P25 for phase_3 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedApril 28, 2010
April 1, 2010
October 7, 2005
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percent change in body weight and in sitting diastolic blood pressure from baseline/randomization (Week 0) to Week 60.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tonstad S, Tykarski A, Weissgarten J, Ivleva A, Levy B, Kumar A, Fitchet M. Efficacy and safety of topiramate in the treatment of obese subjects with essential hypertension. Am J Cardiol. 2005 Jul 15;96(2):243-51. doi: 10.1016/j.amjcard.2005.03.053.
PMID: 16018851RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
March 1, 2001
Study Completion
June 1, 2002
Last Updated
April 28, 2010
Record last verified: 2010-04