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

Roche

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: orlistat [Xenical]; Behavioral: Diet and Exercise

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940628

ML19569

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adolescent patients, 12-14 years of age
• overweight or obese

Exclusion criteria

• age <12 or >14 years
• BMI in normal range

Trial design

60 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: orlistat [Xenical]

Behavioral: Diet and Exercise

2

Other group

Treatment:

Behavioral: Diet and Exercise