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

• ClinicalTrials.gov Identifier: NCT00082251
• Recruitment Status: Completed
• First Posted: May 5, 2004
• Last Update Posted: November 1, 2006
• Sponsor: Kos Pharmaceuticals
• Information provided by: Kos Pharmaceuticals

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Niacin extended release and simvastatin tablets	Phase 3

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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.

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.

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; Bypass Angioplasty Revascularization Investigation. 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.

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.

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.

• ClinicalTrials.gov Identifier: NCT00082251
• Other Study ID Numbers: 019-01-03-CR; SEACOAST
• First Posted: May 5, 2004
• Last Update Posted: November 1, 2006
• Last Verified: October 2006

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

Additional relevant MeSH terms:

Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Niacin; Simvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs