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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 30, 2005 | ||||
| Last Updated Date | June 18, 2009 | ||||
| Start Date ICMJE | December 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
The mean change from baseline to Month 6 in abdominal visceral fat as assessed by computed tomography; the safety of Topiramate for up to 12 months of continued treatment in male subjects with abdominal obesity. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00231608 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mean change and percent change in body weight, and mean change in total abdominal fat, subcutaneous abdominal fat, body composition, and body mass index from baseline to Month 6. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity | ||||
| Official Title ICMJE | The Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity: A 6-Month Double-Blind, Randomized, Placebo-Controlled Study With a 6-Month Open-Label Extension | ||||
| Brief Summary | The purposes of this study are to compare the effects of Topiramate and placebo on abdominal visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12 months of continued treatment in male patients with abdominal obesity. |
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| Detailed Description | Topiramate is not approved for the treatment of obesity. This study is a 6-month randomized, double-blind placebo-controlled study, followed by a 6-month open-label extension study to evaluate the effect of Topiramate on abdominal visceral fat accumulation, a clinical surrogate known to be associated with the complications of obesity such as increased incidence of Type 2 diabetes mellitus, hypertension, and dyslipidemia, and their associated morbidities. Patients will be randomized to receive either daily Topiramate or placebo. Effectiveness will be measured by multiple parameters such as abdominal visceral fat (assessed by computed tomography), total and subcutaneous abdominal fat, body composition, body weight, body mass index, glucose tolerance, lipid profile, blood pressure, Topiramate plasma concentration, or 24 hours energy expenditure (selected patients). Safety evaluation (adverse events, vital signs, 12-lead ECG, clinical laboratory tests) will be conducted throughout the study. The study hypothesis is that Topiramate is effective in reducing abdominal visceral fat in male patients and well tolerated. After the initial 12-week titration phase, patients will receive either Topiramate (200mg twice daily or the maximum dose tolerated) or placebo by mouth for 6-months. Then, patients will receive Topiramate (200mg twice daily or the maximum tolerated dose) for 6-months during the open-label phase. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Drug: topiramate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 68 | ||||
| Completion Date | January 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 25 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00231608 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CR003724 | ||||
| Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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