A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: orlistat [Xenical] (Drug); Diet and Exercise (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Overall contact:
Please reference Study ID Number: ML19569, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
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.
Clinical Details
Official title: Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents
Study design: Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in BMI
Secondary outcome: Adverse events, laboratory parameters
Eligibility
Minimum age: 12 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adolescent patients, 12-14 years of age
- overweight or obese
Exclusion Criteria:
- age <12 or >14 years
- BMI in normal range
Locations and Contacts
Please reference Study ID Number: ML19569, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
KAZAN 420073, Russian Federation; Terminated
YAROSLAVL 150030, Russian Federation; Terminated
SAMARA 443079, Russian Federation; Terminated
NIZHNY NOVGOROD 603136, Russian Federation; Terminated
EKATERINBURG 620028, Russian Federation; Terminated
KRASNOYARSK 660074, Russian Federation; Terminated
TUMEN 625023, Russian Federation; Terminated
NOVOSIBIRSK 630048, Russian Federation; Terminated
KRASNODAR 350013, Russian Federation; Terminated
KHABAROVSK 680063, Russian Federation; Terminated
MOSCOW 117036, Russian Federation; Recruiting
Additional Information
Starting date: September 2006
Ending date: January 2011
Last updated: October 19, 2009
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