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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00261911 History of Changes |
| Other Study ID Numbers: | SB238 |
| Study First Received: | December 2, 2005 |
| Last Updated: | August 30, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Meridia Sibutramine Obesity Adolescent BMI |
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Sibutramine |
Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents Psychotropic Drugs |