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

Hoffmann-La Roche60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Diet and ExerciseBEHAVIORAL

mildly hypocaloric diet and physical exercise

orlistat [Xenical]DRUG

120mg po tid

Eligibility

Sex: ALLMin age: 12 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adolescent patients, 12-14 years of age * overweight or obese Exclusion Criteria: * age \<12 or \>14 years * BMI in normal range

Locations (11)

Unnamed facility

Kazan', Russia

Unnamed facility

Khabarovsk, Russia

Unnamed facility

Krasnodar, Russia

Unnamed facility

Krasnoyarsk, Russia

Outcomes

Primary Outcomes

Change in BMI

Time frame: At each clinic visit, every 4 weeks

Secondary Outcomes

Adverse events, laboratory parameters

Time frame: At each clinic visit, every 4 weeks

Data from ClinicalTrials.gov

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