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Completed

NCT Number: NCT00940628

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kazan', Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age <12 or >14 years
  • BMI in normal range

Treatment and study plan

Diet and Exercise

Behavioral

mildly hypocaloric diet and physical exercise

orlistat [Xenical]

Drug

120mg po tid

Primary outcomes

  1. Change in BMI

    Time frame: At each clinic visit, every 4 weeks

Secondary outcomes

  1. Adverse events, laboratory parameters

    Time frame: At each clinic visit, every 4 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2009
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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