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

• ClinicalTrials.gov Identifier: NCT00940628
• Recruitment Status: Completed
• First Posted: July 16, 2009
• Last Update Posted: April 5, 2016
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: June 16, 2009
• First Posted Date: July 16, 2009
• Last Update Posted Date: April 5, 2016
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 3, 2009): Change in BMI [ Time Frame: At each clinic visit, every 4 weeks ]
• Original Primary Outcome Measures (submitted: July 15, 2009): Change in body mass index (BMI) [ Time Frame: At each clinic visit, every 4 weeks ]
• Current Secondary Outcome Measures (submitted: July 15, 2009): Adverse events, laboratory parameters [ Time Frame: At each clinic visit, every 4 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
• 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
• 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• Behavioral: Diet and Exercise
  mildly hypocaloric diet and physical exercise
• Drug: orlistat [Xenical]
  120mg po tid

Study Arms

• Experimental: 1
  Interventions:

  • Behavioral: Diet and Exercise
  • Drug: orlistat [Xenical]
• 2
  Intervention: Behavioral: Diet and Exercise

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 23, 2013): 60
• Original Estimated Enrollment (submitted: July 15, 2009): 9000
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• age <12 or >14 years
• BMI in normal range

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 14 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT00940628
• Other Study ID Numbers: ML19569
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: April 2016