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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00645255 |
The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily in obese subjects.
Condition | Intervention | Phase |
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Obesity Weight Loss |
Drug: placebo Drug: sibutramine or placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Examine the Longer-Term Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Obese Subjects |
Enrollment: | 466 |
Study Start Date: | September 1998 |
Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Single-blind Placebo Run-in with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
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Drug: placebo
placebo one capsule daily
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2: Placebo Comparator
Double-blind Treatment with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
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Drug: sibutramine or placebo
one capsule daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Peter Bacher, MD, PhD ) |
Study ID Numbers: | SB118 |
Study First Received: | March 24, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00645255 |
Health Authority: | United States: Food and Drug Administration |
Sibutramine Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |
Anti-Obesity Agents Therapeutic Uses Psychotropic Drugs Appetite Depressants |
Central Nervous System Agents Antidepressive Agents Pharmacologic Actions |