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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR MEVACOR

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Clinical Trials for Mevacor

Trial ID Title Status Sponsor Phase Summary
NCT00062556 Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication Completed Kos Pharmaceuticals Phase 3 The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication. At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study. Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.
NCT00071266 The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC Completed Kos Pharmaceuticals Phase 3 The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries. At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study. Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve “intermittent claudication” (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.
NCT00532311 Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia Terminated Takeda Phase 3 The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia
NCT00684723 Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets Completed Mutual Pharmaceutical Company, Inc. Phase 1 The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Mevacor

Condition Name

Condition Name for Mevacor
Intervention Trials
Peripheral Vascular Disease 2
Healthy 2
Intermittent Claudication 2
Healthy Volunteer 1
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Condition MeSH

Condition MeSH for Mevacor
Intervention Trials
Syndrome 2
Vascular Diseases 2
Peripheral Vascular Diseases 2
Peripheral Arterial Disease 2
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Clinical Trial Locations for Mevacor

Trials by Country

Trials by Country for Mevacor
Location Trials
United States 60
Canada 3
Taiwan 2
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Trials by US State

Trials by US State for Mevacor
Location Trials
California 4
Missouri 3
Georgia 3
Florida 3
Pennsylvania 3
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Clinical Trial Progress for Mevacor

Clinical Trial Phase

Clinical Trial Phase for Mevacor
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Mevacor
Clinical Trial Phase Trials
Completed 8
Recruiting 1
Suspended 1
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Clinical Trial Sponsors for Mevacor

Sponsor Name

Sponsor Name for Mevacor
Sponsor Trials
Mutual Pharmaceutical Company, Inc. 2
Kos Pharmaceuticals 2
National Science Council, Taiwan 1
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Sponsor Type

Sponsor Type for Mevacor
Sponsor Trials
Other 11
Industry 5
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Covington
Moodys
AstraZeneca
Citi
Medtronic
Johnson and Johnson
Deloitte
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