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Niacin

Generic Name
Niacin
Brand Names
Advicor, Concept Ob, Irospan 24/6 Kit, Mvc-fluoride, Niacor, Niaspan, Niodan, Simcor, Vitafol-one
Drug Type
Small Molecule
Chemical Formula
C6H5NO2
CAS Number
59-67-6
Unique Ingredient Identifier
2679MF687A
Background

Niacin is a B vitamin used to treat vitamin deficiencies as well as hyperlipidemia, dyslipidemia, hypertriglyceridemia, and to reduce the risk of myocardial infarctions.

Indication

Niacin is indicated to prevent vitamin deficiencies in pediatric and adult patients receiving parenteral nutrition as part of multivitamin intravenous injections. Niacin oral tablets are indicated as a monotherapy or in combination with simvastatin or lovastatin to treat primary hyperlipidemia and mixed dyslipidemia. It can also be used to reduce the risk of nonfatal myocardial infarctions in patients with a history of myocardial infarction and hyperlipidemia. Niacin is also indicated with bile acid binding resins to treat atherosclerosis in patients with coronary artery disease and hyperlipidemia or to treat primary hyperlipidemia. Finally niacin is indicated to treat severe hypertriglyceridemia.

Associated Conditions
Atherosclerosis, High Cholesterol, High Triglyceride Level, Mixed Dyslipidemias, Nonfatal Myocardial Infarction, Pellagra, Primary Hypercholesterolemia, Severe Hypertriglyceridemia (sHTG), Type II Hyperlipidaemia
Associated Therapies
Dietary supplementation

Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

Phase 3
Completed
Conditions
Hypercholesterolemia
First Posted Date
2004-05-05
Last Posted Date
2006-11-01
Lead Sponsor
Kos Pharmaceuticals
Registration Number
NCT00082251

Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)

Phase 3
Completed
Conditions
Hypercholesterolemia
First Posted Date
2004-03-29
Last Posted Date
2006-11-01
Lead Sponsor
Kos Pharmaceuticals
Target Recruit Count
600
Registration Number
NCT00080275

Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL

Phase 4
Completed
Conditions
Dyslipidemia
Coronary Heart Disease
Atherosclerosis
Stroke
Diabetes
First Posted Date
2004-03-12
Last Posted Date
2006-11-01
Lead Sponsor
Kos Pharmaceuticals
Target Recruit Count
300
Registration Number
NCT00079638

The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC

Phase 3
Completed
Conditions
Intermittent Claudication
Peripheral Vascular Disease
First Posted Date
2003-10-20
Last Posted Date
2006-11-02
Lead Sponsor
Kos Pharmaceuticals
Target Recruit Count
870
Registration Number
NCT00071266
Locations
🇺🇸

Penn State College of Medicine, Hershey, Pennsylvania, United States

🇺🇸

North County Internal Medicine, Vista, California, United States

🇺🇸

Care Foundation, Inc, Wausau, Wisconsin, United States

and more 23 locations

Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication

Phase 3
Completed
Conditions
Intermittent Claudication
Peripheral Vascular Disease
First Posted Date
2003-06-12
Last Posted Date
2006-11-01
Lead Sponsor
Kos Pharmaceuticals
Target Recruit Count
366
Registration Number
NCT00062556

Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients

Not Applicable
Completed
Conditions
HIV Infections
Hypercholesterolemia
Hypertriglyceridemia
Diabetes Mellitus
First Posted Date
2002-09-25
Last Posted Date
2011-03-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
30
Registration Number
NCT00046267
Locations
🇺🇸

Washington Univ (St. Louis), St. Louis, Missouri, United States

🇺🇸

Stanford Univ, Stanford, California, United States

🇺🇸

Case Western Reserve Univ, Cleveland, Ohio, United States

and more 13 locations

HDL-Atherosclerosis Treatment Study (HATS)

Phase 3
Completed
Conditions
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
First Posted Date
1999-10-28
Last Posted Date
2016-02-10
Lead Sponsor
University of Washington
Registration Number
NCT00000553

Coronary Drug Project

Phase 3
Completed
Conditions
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Myocardial Infarction
First Posted Date
1999-10-28
Last Posted Date
2013-11-26
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000482

Coronary Drug Project Mortality Surveillance

Not Applicable
Completed
Conditions
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Myocardial Infarction
First Posted Date
1999-10-28
Last Posted Date
2013-11-26
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000483

Cholesterol-Lowering Atherosclerosis Study (CLAS)

Phase 3
Completed
Conditions
Cerebral Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Carotid Artery Diseases
Coronary Arteriosclerosis
Cerebrovascular Disorders
Heart Diseases
Myocardial Ischemia
Atherosclerosis
First Posted Date
1999-10-28
Last Posted Date
2013-12-13
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000599
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