A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.

NCT00261911 | Completed Phase 3

• 1 other identifier: SB238
• Study Type: interventional
• Target: 498
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Keywords

Meridia; Sibutramine; Obesity; Adolescent; BMI

Outcome Measures

Primary Outcomes (1)

• Absolute change in body mass index (BMI) from baseline to endpoint.

  12 months

Secondary Outcomes (5)

• Percent change from Baseline in BMI

  12 months

• Proportions of subjects achieving >= 5% and >=10% BMI and body weight reduction

  12 months

• Absolute and percent change from Baseline in waist circumference

  12 months

• Body composition (DXA)

  12 months

• Lipid and glycemic variables

  12 months

Interventions

sibutramine DRUG

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Both the patient and legal guardian/parent must be able to communicate meaningfully with the investigator, be legally competent, and provide written informed consent/assent.
• All patients must exhibit sufficient comprehension of written materials to be able to follow diet and exercise recommendations, and to complete written behavioral assessments.
• A serum pregnancy test, which must be negative, is required of all females.
• The patient must have at the screening and baseline visits a mean systolic blood pressure \<=130 mm Hg, a diastolic blood pressure \<=85 mm Hg, and a pulse rate \<=95 beats per minute. Treated hypertensives are allowed in the study if medication has been stable for at least 3 months.

You may not qualify if:

• The patient must not have a history of anorexia nervosa.
• The patient must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
• The patient must not have a history of stroke.
• The patient must not have a history of asthma requiring chronic oral corticosteroid therapy. A short course (\<7 days) of oral corticosteroid medication is permitted for an acute exacerbation.
• The patient must not have a history of narrow angle glaucoma.
• The patient must not have a history of gallstones unless status post cholecystectomy.
• The patient must not have a history of seizures with the exception of childhood febrile seizure.
• The patient must not have evidence of possible renal dysfunction (creatinine \>1.7 mg/dL) or hepatic dysfunction (ALT \>50 IU/L, bilirubin \>1.0 mg/dL). Patients must not have evidence of active or chronic Hepatitis B or C infection.
• The patient must not be using any of the following medications at any time during the study: monoamine oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine hydrochloride, selegiline), antidepressant agents (including the use of antidepressant agents for more than 2 weeks during the 90 day period prior to screening), lithium, serotonin reuptake inhibitors, certain opioids (dextromethorphan, meperidine, pentazocine, and fentanyl), prescribed or over-the-counter weight loss agents, centrally acting appetite suppressants, tryptophan, sympathomimetics, serotonergic anti-migraine agents (including sumatriptan succinate, dihydroergotamine, etc.) or any other medication that, in the opinion of the Investigator, may pose harm to the patient, obscure the effects of study medication or interfere with the process of drug absorption, distribution, metabolism, or excretion (i.e., enzyme inducers or enzyme inhibitors).
• Patients may not be taken off an antidepressant for the purposes of entering this study.
• The patient and parent/legal guardian must not have a history of alcohol or drug addiction or substance abuse within the previous two years.
• Patients must not be above the 95th percentile for gender and age for the following categories at Screening, as assessed by the Child Behavior CheckList: "thought problems", "delinquent behavior", "aggressive behavior", or "attention problems".
• The patient must not have a t-score of greater than 65 (significantly above average) for the total Child Depression Inventory score.
• The patient must not have participated in rigorous, structured weight loss programs for more than 2 weeks within the past 6 months prior to screening. Continuing participation in less rigorous programs such as Weight Watchers is allowed; however, the patients must have been a participant for at least 6 months prior to screening to be allowed in the study.
• The patient must not have participated in any investigational drug study within thirty (30) days prior to screening.

Sponsors & Collaborators

• Abbott: lead

Related Publications (2)

• 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.

  PMID: 16847290 RESULT

• 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.

  PMID: 17576783 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

sibutramine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Medical Information 1-800-633-9110

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 6, 2005
• Study Start: July 1, 2000
• Study Completion: February 1, 2002
• Last Updated: August 31, 2007

Record last verified: 2007-08