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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