A Study of Xenical (Orlistat) in Overweight and Obese Adolescents - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00940628

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 III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diets Exercise and Physical Fitness Obesity Obesity in Children

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 ]

Estimated Enrollment:	80
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2011

Arms	Assigned Interventions
1: Experimental	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

Kazan, Russian Federation, 420073

Yaroslavl, Russian Federation, 150030

Samara, Russian Federation, 443079

Nizhny Novgorod, Russian Federation, 603136

Ekaterinburg, Russian Federation, 620028

Moscow, Russian Federation, 117036

Tumen, Russian Federation, 625023

Novosibirsk, Russian Federation, 630048

Krasnodar, Russian Federation, 350013

Khabarovsk, Russian Federation, 680063

Krasnoyarsk, Russian Federation, 660074

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	ML19569
Study First Received:	June 16, 2009
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00940628 History of Changes
Health Authority:	Russia: Federal Service on Surveillance in Healthcare and Social Development of RF

Additional relevant MeSH terms:

Obesity
Molecular Mechanisms of Pharmacological Action
Overweight
Enzyme Inhibitors
Pharmacologic Actions
Body Weight
Signs and Symptoms

Anti-Obesity Agents
Orlistat
Therapeutic Uses
Nutrition Disorders
Overnutrition
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010