Trial Information

Summary: A Study of Xenical (Orlistat) in a Multi-Factorial Approach to Weight Loss Maintenance

Status: No longer recruiting

Protocol Number: ML16868

Sponsor: Roche Pharma (Schweiz) AG

Company Division: Pharmaceutical

Official Scientific Title: Multi-factorial approach associated with orlistat (Xenical) for 4 years' weight loss maintenance in obese patients

Brief Summary: This study will evaluate the efficacy of a multi-factorial approach associated with Xenical in weight loss maintenance during 4 years. The effect of Xenical in combination with diet, physical activity and/or cognitive behavioural therapy will be monitored. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals. Target sample size is 50.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Obesity

Intervention Type: Drug

Intervention Name: orlitstat[Xenical]

Primary Outcome: 1. Change from baseline in body weight at 2 and 4 years.

Key Secondary Outcomes: 1. Change in eating behavior; physical activity; psychological parameters; body composition measured by bioimpedance, skin-fold thickness, and waist to hip ratio; metabolic parameters and arterial blood pressure.

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • body mass index >=30, or >= 28 with risk factors (diabetes, hypertension, hyperlipidemia) before weight-loss phase;
  • documented weight loss of >=10 % of initial body weight obtained with diet with or without psychological therapy and with or without Xenical;

Exclusion Criteria:

  • history or presence of significant medical disorders;
  • abnormal clinical chemistry or hematology results of clinical significance;
  • history or presence of cancer;
  • administration of medicines known to alter body weight.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2002

Trial Registration Date: 03/10/2006

Date Last Updated: 10/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Geneve, Switzerland, 1211
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: November 17, 2008 at 2:34:36 PM


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