Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Switzerland
