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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 is a Phase 2 study that has completed, run by Jack Yanovski. The registered enrollment target is 200 participants.
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).
Interventions
- DRUG Placebo
- DRUG Orlistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 1998-05 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001723
The ClinicalTrials.gov registry entry for NCT00001723 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jack Yanovski, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00001723 reports 0 study locations.
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.
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