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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00261911 |
Purpose
The purpose of this study is to assess the effectiveness of sibutramine on weight loss, reduction in body size and improvement in metabolic risk factors and safety in obese adolescents.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: sibutramine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescents |
| Enrollment: | 498 |
| Study Start Date: | July 2000 |
| Estimated Study Completion Date: | February 2002 |
Eligibility| Ages Eligible for Study: | 12 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | SB238 |
| Study First Received: | December 2, 2005 |
| Last Updated: | August 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00261911 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Meridia Sibutramine Obesity Adolescent BMI |
|
Obesity Psychotropic Drugs Overweight Pharmacologic Actions Body Weight Sibutramine Signs and Symptoms |
Anti-Obesity Agents Therapeutic Uses Nutrition Disorders Appetite Depressants Overnutrition Central Nervous System Agents Antidepressive Agents |