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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Niacin extended release and simvastatin tablets
Sponsored by
Kos Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 3, 2004
    Last Updated
    October 31, 2006
    Sponsor
    Kos Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00082251
    Brief Title
    Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
    Official Title
    Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kos Pharmaceuticals

    4. Oversight

    5. 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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Niacin extended release and simvastatin tablets

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12485966
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15249516
    Citation
    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. Erratum In: Circulation. 2004 Aug 10;110(6):763.
    Results Reference
    background
    PubMed Identifier
    11386890
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12427648
    Citation
    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.
    Results Reference
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    PubMed Identifier
    8678079
    Citation
    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.
    Results Reference
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    PubMed Identifier
    10695686
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10334455
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9761083
    Citation
    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.
    Results Reference
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    PubMed Identifier
    3421570
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3275891
    Citation
    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.
    Results Reference
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