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NCT00045812 · ClinicalTrials.gov registry record · Phase 2
SCH-58235 (Ezetimibe) to Treat Homozygous Sitosterolemia
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00045812: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00045812 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00045812, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study will test the safety and effectiveness of SCH-58235 (Ezetimibe) in lowering sitosterol, plant sterol and cholesterol blood levels in patients with homozygous sitosterolemia when added to the patients' current treatment regimen. Homozygous sitosterolemia is an inherited disorder of sterol metabolism in which an excess of many plant sterols, including sitosterol, is absorbed and not enough excreted. (Sterols are substances used to form hormones, vitamins and membranes found in animal and plant lipids.). Patients can develop atherosclerosis with coronary heart disease as early as childhood, as well as other problems including arthritis, arthralgia, and tendon xanthomas (lipid deposits). Current sitosterolemia treatments may include a low sterol diet, medications, intestinal surgery, or a combination of these. Ezetimibe is a member of a new class of drugs called "specific cholesterol absorption inhibitors" that may lower cholesterol, sitosterol and other plant sterol blood levels. Patients with homozygous sitosterolemia 10 years of age and older may be eligible for this study. Participants will have a medical history and physical examination and will be randomly assigned to one of two treatment groups. One group, which will include about 80 percent of all study participants, will take 10 mg of Ezetimibe a day, and the second group (20 percent of participants) will take a placebo (an inactive look-a-like pill). Patients will have 7 clinic visits during the 12-week study, when some or all of the following procedures and tests will be done: * Measurement of vital signs (heart rate, blood pressure, breathing rate and temperature) * Dietary maintenance - interview about how well that patient is adhering to the diet * Medication review - interview about other medications the patient is taking * Blood draw for tests * Urine sample for tests * Pregnancy test for women of childbearing potential * Electrocardiogram (ECG) to measure the electrical activity of the hea
Interventions
- DRUG SCH-58235
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2001-03 |
| Est. Completion | 2004-04 |
| Phase | Phase 2 |
What the finished NCT00045812 record still lists
NCT00045812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which SCH-58235 is the first listed.
NCT00045812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00045812 about?
NCT00045812 is a clinical study titled "SCH-58235 (Ezetimibe) to Treat Homozygous Sitosterolemia". This study will test the safety and effectiveness of SCH-58235 (Ezetimibe) in lowering sitosterol, plant sterol and cholesterol blood levels in patients with homozygous sitosterolemia when added to the patients' current treatment regimen. Homozygous sitosterolemia is an inherited disorder of sterol ...
What is the current status of trial NCT00045812?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2001-03. Estimated completion is 2004-04.
What interventions are being tested in trial NCT00045812?
The interventions under investigation include: SCH-58235 (DRUG).
Who is sponsoring clinical trial NCT00045812?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00045812's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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