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

NCT ID: NCT00940628

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Diet and Exercise

Intervention Type BEHAVIORAL

mildly hypocaloric diet and physical exercise

orlistat [Xenical]

Intervention Type DRUG

120mg po tid

2

Group Type OTHER

Diet and Exercise

Intervention Type BEHAVIORAL

mildly hypocaloric diet and physical exercise

Interventions

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Diet and Exercise

mildly hypocaloric diet and physical exercise

Intervention Type BEHAVIORAL

orlistat [Xenical]

120mg po tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \<12 or \>14 years
* BMI in normal range
Minimum Eligible Age

12 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Kazan', , Russia

Site Status

Khabarovsk, , Russia

Site Status

Krasnodar, , Russia

Site Status

Krasnoyarsk, , Russia

Site Status

Moscow, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Novosibirsk, , Russia

Site Status

Samara, , Russia

Site Status

Tyumen, , Russia

Site Status

Yaroslavl, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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ML19569

Identifier Type: -

Identifier Source: org_study_id

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