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: October 6, 2014
Last verified: October 2014
  Purpose

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.


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


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: 60
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Diet and Exercise
mildly hypocaloric diet and physical exercise
Drug: orlistat [Xenical]
120mg po tid
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940628     History of Changes
Other Study ID Numbers: ML19569
Study First Received: June 16, 2009
Last Updated: October 6, 2014
Health Authority: Russia: Federal Service on Surveillance in Healthcare and Social Development of RF

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

ClinicalTrials.gov processed this record on October 29, 2014