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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00752726 |
Purpose
Weight loss is associated with changes in body composition. The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass.
| Condition | Intervention | Phase |
|---|---|---|
|
Overweight |
Drug: orlistat |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Effects of Weight Reduction With Orlistat vs. Placebo on Changes in Body Composition |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Females: > 35 inches Males: > 40 inches
4)Diet
a) Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner) b) Willing to follow a hypocaloric diet during the study to achieve weight loss c) Willing to take a daily multivitamin for the duration of the study.
5)General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Exclusion Criteria
Smoking History
Medication
Disease/Surgery
Contacts and Locations| United States, Louisiana | |
| GSK Investigational Site | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: GSK Call Center 877-379-3718 | |
| United States, North Carolina | |
| GSK Investigational Site | Not yet recruiting |
| Durham, North Carolina, United States, 27708 | |
| Contact: GSK Call Center 877-379-3718 | |
| Sweden | |
| GSK Investigational Site | Not yet recruiting |
| Gothenburg, Sweden, SE 405 30 | |
| Contact: GSK Call Center 1-877-379-3718 | |
| Study Director: | GlaxoSmithKline Clinical Trials, PharmD | GlaxoSmithKline |
More Information
| ClinicalTrials.gov Identifier: | NCT00752726 History of Changes |
| Other Study ID Numbers: | W3600586 |
| Study First Received: | September 11, 2008 |
| Last Updated: | September 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Body composition orlistat weight loss |
|
Overweight Body Weight Signs and Symptoms Orlistat Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses |