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).

At least 600 subjects with a similar medical condition to yours will take part in this study, at sites within the United States.

Condition	Treatment or Intervention	Phase
Hypercholesterolemia	Drug: Niacin Extended-Release and simvastatin Tablets	Phase III

Further Study Details: 

Expected Total Enrollment:  600

Objectives: To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.

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 a lipid modifying medication other than Zocor & he/she is willing to discontinue this medication
• Patient has demonstrated at least 75% adherence with Zocor.
• LDL-C levels and/or non HDL-C levels above normal.

Exclusion Criteria:

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

Call OCEANS Team Member. This study will be conducted both in the USA and internationally      (800) 722-4567 

Arizona
      Call for Information, Mesa,  Arizona,  85206,  United States; Recruiting
      Call for Information, Phoenix,  Arizona,  85016,  United States; Recruiting
California
      Call for Information, Sacramento,  California,  95825,  United States; Recruiting
      Call for Information, Long Beach,  California,  90822,  United States; Recruiting
      Call for Information, Carlsbad,  California,  92008,  United States; Recruiting
      Call for Information, San Diego,  California,  92161,  United States; Recruiting
      Call for Information, Rancho Mirage,  California,  92270,  United States; Recruiting
      Call for Information, San Jose,  California,  95120,  United States; Recruiting
      Call for Information, Concord,  California,  94520,  United States; Recruiting
      Call for Information, La Jolla,  California,  92037,  United States; Recruiting
      Call for Information, Los Angeles,  California,  90048,  United States; Recruiting
      Call for Information, Vista,  California,  92083,  United States; Recruiting
Colorado
      Call for Information, Denver,  Colorado,  80222,  United States; Recruiting
Connecticut
      Call for Information, Waterbury,  Connecticut,  06708,  United States; Recruiting
      Call for Information, Guilford,  Connecticut,  06437,  United States; Recruiting
      Call for Information, Fairfield,  Connecticut,  06827,  United States; Recruiting
Delaware
      Call for Information, Newark,  Delaware,  19713-2094,  United States; Recruiting
Florida
      Call for Information, Miami Beach,  Florida,  33140,  United States; Recruiting
      Call for Information, Miami,  Florida,  33173,  United States; Recruiting
      Call for Information, Miami,  Florida,  33176,  United States; Recruiting
      Call for Information, Jacksonville Beach,  Florida,  32207,  United States; Recruiting
      Call for Information, Cooper City,  Florida,  33330,  United States; Recruiting
      Call for Information, West Palm Beach,  Florida,  33401,  United States; Recruiting
      Call for Information, Melbourne,  Florida,  32901,  United States; Recruiting
      Call for Information, Naples,  Florida,  34102,  United States; Recruiting
      Call for Information, Ft. Lauderdale,  Florida,  33316,  United States; Recruiting
      Call for Information, Miami,  Florida,  33143,  United States; Recruiting
      Call for Information, Pembroke Pines,  Florida,  33024,  United States; Recruiting
Georgia
      Call for Information, Decatur,  Georgia,  30033,  United States; Recruiting
      Call for Information, Atlanta,  Georgia,  30309,  United States; Recruiting
      Call for Information, Athens,  Georgia,  30303,  United States; Recruiting
Illinois
      Call for Information, Peoria,  Illinois,  61614,  United States; Recruiting
Indiana
      Call for Information, Fort Wayne,  Indiana,  46805,  United States; Recruiting
Kansas
      Call for Information, Kansas City,  Kansas,  66160,  United States; Recruiting
      Call for Information, Newton,  Kansas,  67114,  United States; Recruiting
      Call for Information, Wichita,  Kansas,  67207,  United States; Recruiting
      Call for Information, Wichita,  Kansas,  67207,  United States; Recruiting
      Call for Information, Arkansas City,  Kansas,  67005,  United States; Recruiting
      Call for Information, Wichita,  Kansas,  67212,  United States; Recruiting
Kentucky
      Call for Information, Erlanger,  Kentucky,  41018,  United States; Recruiting
      Call for Information, Lexington,  Kentucky,  40536-0284,  United States; Recruiting
      Call for Information, Louisville,  Kentucky,  40205,  United States; Recruiting
Maryland
      Call for Information, Oxon Hill,  Maryland,  20745,  United States; Recruiting
      Call for Information, Baltimore,  Maryland,  21201,  United States; Recruiting
      Call for Information, Baltimore,  Maryland,  21205,  United States; Recruiting
Massachusetts
      Call for Information, Boston,  Massachusetts,  02111,  United States; Recruiting
      Call for Information, Brighton,  Massachusetts,  02135,  United States; Recruiting
Missouri
      Call for Information, Chesterfield,  Missouri,  63017,  United States; Recruiting
      Call for Information, St. Louis,  Missouri,  63110,  United States; Recruiting
      Call for Information, St. Louis,  Missouri,  63104,  United States; Recruiting
      Call for Information, Kansas,  Missouri,  64111,  United States; Recruiting
New Jersey
      Call for Information, Lawrenceville,  New Jersey,  08648,  United States; Recruiting
      Call for Information, Mt. Laurel,  New Jersey,  08054,  United States; Recruiting
New Mexico
      Call for Information, Albuquerque,  New Mexico,  87131,  United States; Recruiting
New York
      Call for Information, Lewiston,  New York,  14092,  United States; Recruiting
      Call for Information, East Syracuse,  New York,  13057,  United States; Recruiting
North Carolina
      Call for Information, Durham,  North Carolina,  27710,  United States; Recruiting
      Call for Information, Charlotte,  North Carolina,  28204,  United States; Recruiting
      Call for Information, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Ohio
      Call for Information, Mansfield,  Ohio,  44906,  United States; Recruiting
      Call for Information, Cleveland,  Ohio,  44195,  United States; Recruiting
      Call for Information, Newark,  Ohio,  43055,  United States; Recruiting
      Call for Information, Cincinnati,  Ohio,  45219,  United States; Recruiting
      Call for Information, Athens,  Ohio,  45701,  United States; Recruiting
      Call for Information, Kettering,  Ohio,  45429,  United States; Recruiting
Pennsylvania
      Call for Information, Philadelphia,  Pennsylvania,  19148,  United States; Recruiting
      Call for Information, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
      Call for Information, Upland,  Pennsylvania,  19013,  United States; Recruiting
Rhode Island
      Call for Information, N. Smithfield,  Rhode Island,  02896,  United States; Recruiting
South Carolina
      Call for Information, Charleston,  South Carolina,  29403,  United States; Recruiting
Tennessee
      Call for Information, Selmer,  Tennessee,  38375,  United States; Recruiting
      Call for Information, Jackson,  Tennessee,  38305,  United States; Recruiting
Texas
      Call for Information, Irving,  Texas,  75039,  United States; Recruiting
      Call for Information, Corsicana,  Texas,  75110,  United States; Recruiting
      Call for Information, Dallas,  Texas,  75230,  United States; Recruiting
      Call for Information, Houston,  Texas,  77030,  United States; Recruiting
      Call for Information, Corpus Christi,  Texas,  78404,  United States; Recruiting
Utah
      Call for Information, Ogden,  Utah,  84403,  United States; Recruiting
Virginia
      Call for Information, Richmond,  Virginia,  23249,  United States; Recruiting
      Call for Information, Warrenton,  Virginia,  20186,  United States; Recruiting
Washington
      Call for Information, Burien,  Washington,  98166,  United States; Recruiting
      Call for Information, Seattle,  Washington,  98104,  United States; Recruiting
      Call for Information, Spokane,  Washington,  99208,  United States; Recruiting
West Virginia
      Call for Information, Charleston,  West Virginia,  25304,  United States; Recruiting
      Call for Information, Huntington,  West Virginia,  25701,  United States; Recruiting
Wisconsin
      Call for Information, Madison,  Wisconsin,  53715,  United States; Recruiting
      Call for Information, Madison,  Wisconsin,  53715,  United States; Recruiting

Study ID Numbers:  OCEANS; OCEANS
Record last reviewed:  August 2004
Last Updated:  February 15, 2005
Record first received:  March 25, 2004
ClinicalTrials.gov Identifier:  NCT00080275
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08