Not Signed In -
Simvastatin |
Zocor |
Clinical Trial: Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
This study is currently recruiting patients.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: Niacin extended release and simvastatin tablets | Phase III |
MedlinePlus related topics: Cholesterol
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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 above, Genders Eligible for Study: Both
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
- Patient has demonstrated at least 75% adherence with Zocor
- 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
Location and Contact Information
Alabama
Call for Information, Mobile, Alabama, 36693, United States; Recruiting
Call for Information, Birmingham, Alabama, 35209, United States; Recruiting
Arizona
Call for Information, Mesa, Arizona, 85206, United States; Recruiting
Call for Information, Tucson, Arizona, 85710, United States; Recruiting
California
Call for Information, Torrance, California, 90505, United States; Recruiting
Call for Information, Palo Alto, California, 94304-1825, United States; Recruiting
Call for Information, San Diego, California, 92108, United States; Recruiting
District of Columbia
Call for Information, Washington, District of Columbia, 20037, United States; Recruiting
Florida
Call for Information, Hollywood, Florida, 33021, United States; Recruiting
Call for Information, Coral Gables, Florida, 33146, United States; Recruiting
Call for Information, Miami, Florida, 33136, United States; Recruiting
Call for Information, Gainesville, Florida, 32610, United States; Recruiting
Call for Information, Fort Meyers, Florida, 33919, United States; Recruiting
Georgia
Call for Information, Atlanta, Georgia, 30342, United States; Recruiting
Idaho
Call for Information, Boise, Idaho, 83702, United States; Recruiting
Illinois
Call for Information, Chicago, Illinois, 60607, United States; Recruiting
Call for Information, Chicago, Illinois, 60611, United States; Recruiting
Indiana
Call for Information, Indianapolis, Indiana, 46260, United States; Recruiting
Kansas
Call for Information, Kansas City, Kansas, 66112, United States; Recruiting
Louisiana
Call for Information, New Orleans, Louisiana, 70119, United States; Recruiting
Call for Information, New Orleans, Louisiana, 70124, United States; Recruiting
Maine
Call for Information, Auburn, Maine, 04210, United States; Recruiting
Minnesota
Call for Information, Minneapolis, Minnesota, 55404, United States; Recruiting
Missouri
Call for Information, St. Louis, Missouri, 63104, United States; Recruiting
New York
Call for Information, Syracuse, New York, 13202, United States; Recruiting
Call for Information, Rochester, New York, 14618, United States; Recruiting
Call for Information, New York, New York, 10021, United States; Recruiting
North Carolina
Call for Information, Winston Salem, North Carolina, 27103, United States; Recruiting
Ohio
Call for Information, Dayton, Ohio, 45458, United States; Recruiting
Call for Information, Mogadore, Ohio, 44260, United States; Recruiting
Call for Information, Columbus, Ohio, 43212, United States; Recruiting
Oregon
Call for Information, Hillsboro, Oregon, 97123, United States; Recruiting
Pennsylvania
Call for Information, Philadelphia, Pennsylvania, 19107, United States; Recruiting
South Carolina
Call for Information, Greer, South Carolina, 29651, United States; Recruiting
Call for Information, Anderson, South Carolina, 29621, United States; Recruiting
Texas
Call for Information, San Antonio, Texas, 78224, United States; Recruiting
Call for Information, Houston, Texas, 77030, United States; Recruiting
Call for Information, Amarillo, Texas, 79106, United States; Recruiting
Call for Information, Houston, Texas, 77024, United States; Recruiting
Utah
Call for Information, Salt Lake City, Utah, 84108, United States; Recruiting
Virginia
Call for Information, Norfolk, Virginia, 23502, United States; Recruiting
Call for Information, Richmond, Virginia, 23294, United States; Recruiting
Puerto Rico
Call for Information, San Juan, 00909-1711, Puerto Rico; Recruiting
More Information
http://www.kospharm.com
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.
Record last reviewed: February 2005
Last Updated: February 4, 2005
Record first received: May 3, 2004
ClinicalTrials.gov Identifier: NCT00082251
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Simvastatin (Drug Digest)
- Simvastatin (Cleveland Clinic)
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