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NCT00001723 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
A Phase 2 study, sponsored by Jack Yanovski.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT00001723: Completed Phase 2 study, sponsored by Jack Yanovski.
NCT00001723 is a Phase 2 study that has completed, run by Jack Yanovski. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001723, a Phase 2 study, has completed, sponsored by Jack Yanovski.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Orlistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 1998-05 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT00001723 record still lists
NCT00001723 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00001723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001723 about?
NCT00001723 is a clinical study titled "Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases". Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of ob...
What is the current status of trial NCT00001723?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 1998-05. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00001723?
The interventions under investigation include: Placebo (DRUG), Orlistat (DRUG).
Who is sponsoring clinical trial NCT00001723?
This trial is sponsored by Jack Yanovski, which has 1 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001723's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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