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Last Updated: October 20, 2019

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CLINICAL TRIALS PROFILE FOR EZETIMIBE

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Clinical Trials for Ezetimibe

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ezetimibe

Condition Name

Condition Name for Ezetimibe
Intervention Trials
Hypercholesterolemia 123
Atherosclerosis 22
Hyperlipidemia 21
Coronary Artery Disease 14
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Condition MeSH

Condition MeSH for Ezetimibe
Intervention Trials
Hypercholesterolemia 147
Coronary Disease 39
Coronary Artery Disease 39
Myocardial Ischemia 38
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Clinical Trial Locations for Ezetimibe

Trials by Country

Trials by Country for Ezetimibe
Location Trials
United States 473
Canada 49
Korea, Republic of 29
United Kingdom 27
Australia 24
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Trials by US State

Trials by US State for Ezetimibe
Location Trials
California 25
Ohio 23
Texas 22
Florida 21
North Carolina 20
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Clinical Trial Progress for Ezetimibe

Clinical Trial Phase

Clinical Trial Phase for Ezetimibe
Clinical Trial Phase Trials
Phase 4 88
Phase 3 108
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ezetimibe
Clinical Trial Phase Trials
Completed 196
Recruiting 23
Not yet recruiting 21
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Clinical Trial Sponsors for Ezetimibe

Sponsor Name

Sponsor Name for Ezetimibe
Sponsor Trials
Merck Sharp & Dohme Corp. 116
Sanofi 10
Amgen 10
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Sponsor Type

Sponsor Type for Ezetimibe
Sponsor Trials
Industry 215
Other 141
NIH 7
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Serving leading biopharmaceutical companies globally:

Colorcon
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