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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Diet and Exercise Drug: orlistat [Xenical] Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in BMI [ Time Frame: At each clinic visit, every 4 weeks ]

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

Eligibility Criteria
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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
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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
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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
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940628    
Other Study ID Numbers: ML19569
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents