A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
Sponsor study identifier
interventional
113
0 countries
N/A
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2004
Actual (reported)The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2004
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.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
October 2004
Actual (reported)September 30, 2005
Actual (reported)October 4, 2005
Actual (reported)Percent change in body weight from baseline to Week 16.
Changes in body weight, body mass index,anthropometric measurements (waste and hip circumference and their ratio),fasting blood glucose and lipid profile from baseline to Week 16; safety evaluations including incidence of adverse events during the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
113 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
October 2004
Actual (reported)Last Updated
June 8, 2011
Record last verified: 2011-01
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Source: ClinicalTrials.gov.
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