A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Orlistat

Criteria

Inclusion Criteria:

• adolescent patients, 12-14 years of age

• overweight or obese

Exclusion Criteria:

• age <12 or >14 years

• BMI in normal range