| Trial ID: | L3900 |
| Source ID: | NCT00001723
|
| Associated Drug: |
Orlistat
|
| Title: |
Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00001723/results
|
| Conditions: |
Diabetes Mellitus|Hypertension|Metabolic Disease|Obesity|Sleep Apnea Syndrome
|
| Interventions: |
DRUG: Orlistat|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in BMI Standard Deviation Score, Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190., baseline to 6 months | Secondary: Change in Body Weight, Weight in kg, baseline to 6 months|Change in Body Mass Index, BMI is calculated in kg/m2. Change from baseline to 6 months of treatment, baseline to 6 months|Change in Body Fat (kg), body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA), baseline to 6 months|Effect of Race on Change in Weight (kg), Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black), baseline to 6 months
|
| Sponsor/Collaborators: |
Sponsor: Jack Yanovski | Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Roche Pharma AG
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE2
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
1998-05
|
| Completion Date: |
2011-10
|
| Results First Posted: |
2012-12-18
|
| Last Update Posted: |
2012-12-18
|
| Locations: |
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00001723
|
