A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

Last updated: April 2, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Obesity

Treatment

N/A

Clinical Study ID

NCT00940628
ML19569
  • Ages 12-14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adolescent patients, 12-14 years of age

  • overweight or obese

Exclusion

Exclusion Criteria:

  • age <12 or >14 years

  • BMI in normal range

Study Design

Total Participants: 60
Study Start date:
April 01, 2008
Estimated Completion Date:
September 30, 2010

Connect with a study center

  • Ekaterinburg, 620028
    Russian Federation

    Site Not Available

  • Kazan, 420073
    Russian Federation

    Site Not Available

  • Khabarovsk, 680063
    Russian Federation

    Site Not Available

  • Krasnodar, 350013
    Russian Federation

    Site Not Available

  • Krasnoyarsk, 660074
    Russian Federation

    Site Not Available

  • Moscow, 117036
    Russian Federation

    Site Not Available

  • Nizhny Novgorod, 603136
    Russian Federation

    Site Not Available

  • Novosibirsk, 630048
    Russian Federation

    Site Not Available

  • Samara, 443079
    Russian Federation

    Site Not Available

  • Tumen, 625023
    Russian Federation

    Site Not Available

  • Yaroslavl, 150030
    Russian Federation

    Site Not Available

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