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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940628
First Posted: July 16, 2009
Last Update Posted: April 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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 Behavioral: Diet and Exercise Drug: orlistat [Xenical] Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (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 ]

Secondary Outcome Measures:
  • Adverse events, laboratory parameters [ Time Frame: At each clinic visit, every 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940628     History of Changes
Other Study ID Numbers: ML19569
First Submitted: June 16, 2009
First Posted: July 16, 2009
Last Update Posted: April 5, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents