A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity

• Status: Completed
• Trial end date: 2002-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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