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

Purpose

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).

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Niacin extended release and simvastatin tablets	Phase III

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

Drug Information available for:

Simvastatin Cholest-5-en-3-ol (3beta)- Niacin Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Kos Pharmaceuticals:

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives
HbA1c ≥ 9% in diabetic patients

Contacts and Locations

No Contacts or Locations Provided

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.

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.

Cui Y, Blumenthal RS, Flaws JA, Whiteman MK, Langenberg P, Bachorik PS, Bush TL. Non-high-density lipoprotein cholesterol level as a predictor of cardiovascular disease mortality. Arch Intern Med. 2001 Jun 11;161(11):1413-9.

Bittner V, Hardison R, Kelsey SF, Weiner BH, Jacobs AK, Sopko G. Non-high-density lipoprotein cholesterol levels predict five-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 2002 Nov 12;106(20):2537-42.

Marcelino JJ, Feingold KR. Inadequate treatment with HMG-CoA reductase inhibitors by health care providers. Am J Med. 1996 Jun;100(6):605-10.

Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med. 2000 Feb 28;160(4):459-67.

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. No abstract available.

Guyton JR, Goldberg AC, Kreisberg RA, Sprecher DL, Superko HR, O'Connor CM. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol. 1998 Sep 15;82(6):737-43.

Reaven P, Witztum JL. Lovastatin, nicotinic acid, and rhabdomyolysis. Ann Intern Med. 1988 Oct 1;109(7):597-8. No abstract available.

Norman DJ, Illingworth DR, Munson J, Hosenpud J. Myolysis and acute renal failure in a heart-transplant recipient receiving lovastatin. N Engl J Med. 1988 Jan 7;318(1):46-7. No abstract available.

Study ID Numbers:	019-01-03-CR, SEACOAST
First Received:	May 3, 2004
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00082251
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kos Pharmaceuticals:

Dyslipidemia

High Blood Cholesterol

Coronary Heart Disease

Hypertension

National Cholesterol Education Program

Adult Treatment Panel III

Niacin

Simvastatin

Diabetes

Peripheral Vascular Disease

Cerebrovascular disease

Stroke

High-Density Lipoprotein Cholesterol

Hydroxymethyl Glutaryl Coenzyme A

High-Sensitivity C-Reactive Protein

Low-Density Lipoprotein Cholesterol

Lipoprotein (a)

Lipoprotein A-I

Total Cholesterol

Triglycerides

Study placed in the following topic categories:

Heart Diseases

Peripheral Vascular Diseases

Hyperlipidemias

Metabolic Diseases

Cerebral Infarction

Simvastatin

Stroke

Vascular Diseases

Diabetes Mellitus

Cerebrovascular Disorders

Coronary Disease

Nicotinic Acids

Metabolic disorder

Niacin

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Hypertension

Additional relevant MeSH terms:

Antimetabolites

Vasodilator Agents

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Antilipemic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Anticholesteremic Agents

Cardiovascular Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

Therapeutic Uses

Vitamins

Micronutrients

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Kos Pharmaceuticals
Information provided by:	Kos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00082251