Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940628
First received: June 16, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Drug: orlistat [Xenical]
Behavioral: Diet and Exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Orlistat
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in BMI [ Time Frame: At each clinic visit, every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, laboratory parameters [ Time Frame: At each clinic visit, every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: September 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: orlistat [Xenical]
120mg po tid
Behavioral: Diet and Exercise
mildly hypocaloric diet and physical exercise
2 Behavioral: Diet and Exercise
mildly hypocaloric diet and physical exercise

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age <12 or >14 years
  • BMI in normal range
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940628

Locations
Russian Federation
Ekaterinburg, Russian Federation, 620028
Kazan, Russian Federation, 420073
Khabarovsk, Russian Federation, 680063
Krasnodar, Russian Federation, 350013
Krasnoyarsk, Russian Federation, 660074
Moscow, Russian Federation, 117036
Nizhny Novgorod, Russian Federation, 603136
Novosibirsk, Russian Federation, 630048
Samara, Russian Federation, 443079
Tumen, Russian Federation, 625023
Yaroslavl, Russian Federation, 150030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940628     History of Changes
Other Study ID Numbers: ML19569
Study First Received: June 16, 2009
Last Updated: July 19, 2011
Health Authority: Russia: Federal Service on Surveillance in Healthcare and Social Development of RF

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013