Status:
COMPLETED
A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Eligibility:
MALE
25-55 years
Phase:
PHASE2
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 conti...
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 eff...
Eligibility Criteria
Inclusion
- BMI \>= 27 and =\< 40
- a waist circumference \>= 100 cm (39.4 inches)
- Baseline weight must be stable (varying no more than 4 kg (8.8 lbs)) for at least two months prior to enrollment
- Must be sedentary (less than one session of continuous moderate physical activity of 30 min/week)
- Must have blood lipid disorder
- Must be non-smokers
Exclusion
- Patients with endocrine disease or other physical causes of obesity
- Patients with significantly abnormal hepatic liver function tests or renal disease
- History of schizophrenia, psychotic, or major affective disorder
- History of epilepsy
- History of eating disorders
- History of any other significant medical conditions
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2002
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00231608
Start Date
December 1 1998
End Date
January 1 2002
Last Update
June 8 2011
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