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Therapeutic Areas: Endocrinology
Disease Category: Obesity
Trial Information
A study of Xenical (Orlistat) in Overweight and Obese Adolescents
Status: Recruiting
Protocol Number: ML19569
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific Title: Open-label comparative randomized study of the efficacy and safety of orlistat (Xenical) in complex therapy of obesity and metabolic disorders in adolescents
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 hypocalorific 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.
Target sample size is
9000
.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation:
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Obesity
Intervention Type: Drug
Intervention Name: orlistat [Xenical]
Primary Outcome: 1
.
Change in BMI
Time frame:
At each clinic visit, every 4 weeks
Key Secondary Outcomes: 1. Adverse events, laboratory parameters Time frame: At each clinic visit, every 4 weeks
Inclusion Criteria:
- adolescent patients, 12-14 years of age
- overweight or obese
Exclusion Criteria:
- age <12 or >14 years
- BMI in normal range
Gender: Males or Females
Age Limits: Min: 12 Years Max: 14 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: September, 2006
Trial Registration Date: 06/15/2009
Date Last Updated: 09/16/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Nizhny Novgorod 603076
Russian Federation
Phone: 888-662-6728 (U.S. Only)
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