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CLINICAL TRIALS PROFILE FOR EZETIMIBE

Clinical Trials for Ezetimibe

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045812	SCH-58235 (Ezetimibe) to Treat Homozygous Sitosterolemia	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2001-03-01	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 heart - Blood draw to determine sitosterol, other plant sterol levels, and lipid levels (cholesterol and other blood lipid concentrations) - Xanthoma measurement (with a ruler and X-ray of the foot)
NCT00079638	Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL	Completed	Kos Pharmaceuticals	Phase 4	2004-04-01	The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
NCT00090298	Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-04-01	A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.
NCT00092560	Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-12-01	The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
NCT00092573	Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-04-01	The purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
NCT00092586	Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-09-01	The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.
NCT00092599	Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-02-01	This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.
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