drugset / Trial / NCT00261911
A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2000-07
- Primary completion
- —
- Completion
- 2002-02
Outcome
Met primary endpoint
paper The estimated mean treatment group difference at month 12 (linear mixed-effects model) favored sibutramine for change from baseline in BMI (-2.9 kg/m2 [95% CI, -3.5 to -2.2 kg/m2]) PMID 16847290 ↗
paper (P < 0.001 for both). PMID 16847290 ↗
Publications
- Results Berkowitz RI, Fujioka K, Daniels SR, Hoppin AG, Owen S, Perry AC, Sothern MS, Renz CL, Pirner MA, Walch JK, Jasinsky O, Hewkin AC, Blakesley VA; Sibutramine Adolescent Study Group. Effects of sibutramine treatment in obese adolescents: a randomized trial. Ann Intern Med. 2006 Jul 18;145(2):81-90. doi: 10.7326/0003-4819-145-2-200607180-00005.
- Daniels SR, Long B, Crow S, Styne D, Sothern M, Vargas-Rodriguez I, Harris L, Walch J, Jasinsky O, Cwik K, Hewkin A, Blakesley V; Sibutramine Adolescent Study Group. Cardiovascular effects of sibutramine in the treatment of obese adolescents: results of a randomized, double-blind, placebo-controlled study. Pediatrics. 2007 Jul;120(1):e147-57. doi: 10.1542/peds.2006-2137. Epub 2007 Jun 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sibutramine | Small molecule | 10 mg | — |
| Subject | Sibutramine | Small molecule | 15 mg | — |