A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Overview
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.
Full Title of Study: “Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2010
Interventions
- Behavioral: Diet and Exercise
- mildly hypocaloric diet and physical exercise
- Drug: orlistat [Xenical]
- 120mg po tid
Arms, Groups and Cohorts
- Experimental: 1
- Other: 2
Clinical Trial Outcome Measures
Primary Measures
- Change in BMI
- Time Frame: At each clinic visit, every 4 weeks
Secondary Measures
- Adverse events, laboratory parameters
- Time Frame: At each clinic visit, every 4 weeks
Participating in This Clinical Trial
Inclusion Criteria
- adolescent patients, 12-14 years of age – overweight or obese Exclusion Criteria:
- age <12 or >14 years – BMI in normal range
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: 14 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hoffmann-La Roche
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Clinical Trials, Study Director, Hoffmann-La Roche
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