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
Sponsor study identifier
interventional
531
0 countries
N/A
Study Start
March 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 2002
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2002
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2001
Date type not reportedThis date has not been verified as actual or estimated.
June 2002
Actual (reported)October 7, 2005
Actual (reported)October 12, 2005
Actual (reported)The percent change in body weight and in sitting diastolic blood pressure from baseline/randomization (Week 0) to Week 60.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
531 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
March 2001
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
June 2002
Actual (reported)Last Updated
April 28, 2010
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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