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Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults

NCT02706067 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-04-05

No results posted yet for this study

Summary

This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.

Conditions

Interventions

DRUG

Orlistat

Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent \[%\] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706067 on ClinicalTrials.gov