A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
NCT00940628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2016-04-05
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.
Conditions
Interventions
- BEHAVIORAL
-
Diet and Exercise
mildly hypocaloric diet and physical exercise
- DRUG
-
orlistat [Xenical]
120mg po tid
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 12 Years
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2010-09-30
- Completion
- 2010-09-30
Countries
- Russia
Study Locations
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