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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940628
First received: June 16, 2009
Last updated: July 7, 2014
Last verified: July 2014

June 16, 2009
July 7, 2014
April 2008
September 2010   (final data collection date for primary outcome measure)
Change in BMI [ Time Frame: At each clinic visit, every 4 weeks ] [ Designated as safety issue: No ]
Change in body mass index (BMI) [ Time Frame: At each clinic visit, every 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00940628 on ClinicalTrials.gov Archive Site
Adverse events, laboratory parameters [ Time Frame: At each clinic visit, every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents

This 2 arm study will assess the effect of Xenical on body mass index (BMI)in ob ese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exer cise, 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Drug: orlistat [Xenical]
    120mg po tid
  • Behavioral: Diet and Exercise
    mildly hypocaloric diet and physical exercise
  • Experimental: 1
    Interventions:
    • Drug: orlistat [Xenical]
    • Behavioral: Diet and Exercise
  • 2
    Intervention: Behavioral: Diet and Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adolescent patients, 12-14 years of age
  • overweight or obese

Exclusion Criteria:

  • age <12 or >14 years
  • BMI in normal range
Both
12 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00940628
ML19569
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP