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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR NIASPAN

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Clinical Trials for Niaspan

Trial ID Title Status Sponsor Phase Summary
NCT00046267 Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A The purpose of this study is to evaluate the safety, efficacy, and tolerability of extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected patients.
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.
NCT00079638 Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL Completed Kos Pharmaceuticals Phase 4 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Niaspan

Condition Name

Condition Name for Niaspan
Intervention Trials
Dyslipidemia 9
Atherosclerosis 6
Hypercholesterolemia 4
Hyperlipidemia 3
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Condition MeSH

Condition MeSH for Niaspan
Intervention Trials
Dyslipidemias 11
Atherosclerosis 7
Flushing 5
Coronary Artery Disease 5
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Clinical Trial Locations for Niaspan

Trials by Country

Trials by Country for Niaspan
Location Trials
United States 119
Canada 16
France 2
United Kingdom 2
Venezuela 1
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Trials by US State

Trials by US State for Niaspan
Location Trials
Pennsylvania 10
Texas 7
Florida 7
North Carolina 6
California 6
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Clinical Trial Progress for Niaspan

Clinical Trial Phase

Clinical Trial Phase for Niaspan
Clinical Trial Phase Trials
Phase 4 7
Phase 3 10
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Niaspan
Clinical Trial Phase Trials
Completed 32
Unknown status 3
Terminated 3
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Clinical Trial Sponsors for Niaspan

Sponsor Name

Sponsor Name for Niaspan
Sponsor Trials
Merck Sharp & Dohme Corp. 8
Abbott 6
University of Pennsylvania 5
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Sponsor Type

Sponsor Type for Niaspan
Sponsor Trials
Industry 27
Other 26
NIH 6
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