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NCT00099996 · ClinicalTrials.gov registry record · Phase 3
Higher-Dose Ezetimibe to Treat Homozygous Sitosterolemia
A Phase 3 study of Heart Diseases and Metabolism, Inborn Errors, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT00099996 is a Phase 3 study of Heart Diseases and Metabolism, Inborn Errors that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 3 participants, below the 5,532-participant average among 85 other Heart Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00099996, a Phase 3 study of Heart Diseases and Metabolism, Inborn Errors, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety and effectiveness of 40 mg of ezetimibe (Zetia ) daily in lowering blood levels of cholesterol and of the plant sterols sitosterol and campesterol in patients with homozygous sitosterolemia, an inherited disorder of sterol metabolism. (Sterols are alcohol substances found in animal and plant fats.) In this disorder, an excess of many plant sterols is absorbed and not enough excreted. Patients can develop atherosclerosis and coronary heart disease as early as childhood, as well as other problems including arthritis, arthralgia, and tendon xanthomas (lipid deposits). Current treatment consists of ezetimibe 10 mg, dietary restriction of plant and shellfish sterols, and bile salt binding resins. Ezetimibe is a cholesterol-lowering drug that inhibits intestinal absorption of cholesterol and structurally related plant sterols across the intestinal wall. Patients with homozygous sitosterolemia who are between 18 and 85 years of age have completed NHLBI's 1-year study of ezetimibe at 10 mg a day may be eligible for this study. All participants maintain their current stable diet and take a 10-mg pill of ezetimibe daily for 26 weeks. They are also randomly selected to take either an additional 30-mg pill of ezetimibe or a placebo (look-alike pill with no active ingredients). Patients fast for at least 12 hours before each of 6 visits scheduled during the course of the study. At these visits, patients undergo some or all of the following procedures for monitoring their health and evaluating their response to treatment: * Medical history and review of medications * Physical examination * Measurement of vital signs (pulse rate, blood pressure, breathing rate and temperature) * Review of dietary maintenance * Measurements of height, weight, and waist circumference * Measurement (with ruler) and photographs of non-Achilles xanthoma * X-ray of Achilles tendon * Blood draw and urine collection * Pregnancy test for women of childbearing potential
Conditions Studied
Interventions
- DRUG Ezetimibe
- DRUG SCH-58235
Study Locations (1)
Maryland
- National Heart, Lung and Blood Institute (NHLBI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2004-12 |
| Est. Completion | 2005-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00099996
The ClinicalTrials.gov registry entry for NCT00099996 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,532-participant average among 85 other Heart Diseases trials with a reported enrollment target (100% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Heart Diseases appearing as the primary indexed condition, and to 2 interventions - of which Ezetimibe is the first listed.
NCT00099996 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00099996 about?
NCT00099996 is a clinical study titled "Higher-Dose Ezetimibe to Treat Homozygous Sitosterolemia". This study will test the safety and effectiveness of 40 mg of ezetimibe (Zetia ) daily in lowering blood levels of cholesterol and of the plant sterols sitosterol and campesterol in patients with homozygous sitosterolemia, an inherited disorder of sterol metabolism. (Sterols are alcohol substances f...
What is the current status of trial NCT00099996?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2004-12. Estimated completion is 2005-12.
What conditions does trial NCT00099996 study?
This clinical trial studies the following conditions: Heart Diseases, Metabolism, Inborn Errors.
What interventions are being tested in trial NCT00099996?
The interventions under investigation include: Ezetimibe (DRUG), SCH-58235 (DRUG).
Who is sponsoring clinical trial NCT00099996?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00099996 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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