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

NCT00082251 | Completed Phase 3

• 2 other identifiers: 019-01-03-CRSEACOAST
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypercholesterolemia

Keywords

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

Interventions

Niacin extended release and simvastatin tablets DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kos Pharmaceuticals: lead

Related Publications (10)

• 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.

  PMID: 12485966 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000133317.49796.0E.

  PMID: 15249516 BACKGROUND

• 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. doi: 10.1001/archinte.161.11.1413.

  PMID: 11386890 BACKGROUND

• 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. doi: 10.1161/01.cir.0000038496.57570.06.

  PMID: 12427648 BACKGROUND

• Marcelino JJ, Feingold KR. Inadequate treatment with HMG-CoA reductase inhibitors by health care providers. Am J Med. 1996 Jun;100(6):605-10. doi: 10.1016/s0002-9343(96)00011-3.

  PMID: 8678079 BACKGROUND

• 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. doi: 10.1001/archinte.160.4.459.

  PMID: 10695686 BACKGROUND

• 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. doi: 10.1016/s0735-1097(99)00190-4. No abstract available.

  PMID: 10334455 BACKGROUND

• 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. doi: 10.1016/s0002-9149(98)00448-2.

  PMID: 9761083 BACKGROUND

• Reaven P, Witztum JL. Lovastatin, nicotinic acid, and rhabdomyolysis. Ann Intern Med. 1988 Oct 1;109(7):597-8. doi: 10.7326/0003-4819-109-7-597_2. No abstract available.

  PMID: 3421570 BACKGROUND

• 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. doi: 10.1056/NEJM198801073180110. No abstract available.

  PMID: 3275891 BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias; Coronary Disease; Hypertension; Diabetes Mellitus; Peripheral Vascular Diseases; Cerebrovascular Disorders; Stroke

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2004
• First Posted: May 5, 2004
• Last Updated: November 1, 2006

Record last verified: 2006-10