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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Behavioral: Diet and Exercise; Drug: orlistat [Xenical]

• Registration Number: NCT00940628
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-02
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Diet and Exercise	-
1	orlistat [Xenical]	-
2	Diet and Exercise	-

Primary Outcome Measures

Name	Time	Method
Change in BMI	At each clinic visit, every 4 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events, laboratory parameters	At each clinic visit, every 4 weeks