Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
This study has been completed.
First Posted: May 5, 2004
Last Update Posted: November 1, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by:
The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).
Drug: Niacin extended release and simvastatin tablets
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
The purpose of this study is to compare the efficacy and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).
Information from the National Library of Medicine
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|Ages Eligible for Study:
||21 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Patient has primary Type II hyperlipidemia or mixed dyslipidemia
- If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications
- Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
- LDL-C levels and/or Non HDL-C levels above normal for patients
This study will be conducted both in the USA and internationally.
- Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives
- HbA1c ≥ 9% in diabetic patients
No Contacts or Locations Provided
Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13;110(2):227-39. Review. Erratum in: Circulation. 2004 Aug 10;110(6):763.
Mosca L, Grundy SM, Judelson D, King K, Limacher M, Oparil S, Pasternak R, Pearson TA, Redberg RF, Smith SC Jr, Winston M, Zinberg S. AHA/ACC scientific statement: consensus panel statement. Guide to preventive cardiology for women. American Heart Association/American College of Cardiology. J Am Coll Cardiol. 1999 May;33(6):1751-5. Review.
History of Changes
|Other Study ID Numbers:
||May 3, 2004
||May 5, 2004
|Last Update Posted:
||November 1, 2006
Keywords provided by Kos Pharmaceuticals:
High Blood Cholesterol
Coronary Heart Disease
National Cholesterol Education Program
Adult Treatment Panel III
Peripheral Vascular Disease
High-Density Lipoprotein Cholesterol
Hydroxymethyl Glutaryl Coenzyme A
High-Sensitivity C-Reactive Protein
Low-Density Lipoprotein Cholesterol
Additional relevant MeSH terms:
Lipid Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Vitamin B Complex
Physiological Effects of Drugs