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Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)

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 Niacin, Statin, Zocor, Simvastatin, Coronary Heart Disease, Dyslipidemia, Atherosclerosis, Hypercholesterolemia, Stroke, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol, Lipoprotein, Lipid, Niacin ER/simvastatin, 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 a lipid modifying medication other than Zocor & he/she is willing to discontinue this medication LDL-C levels and/or non HDL-C levels above normal. Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study. 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
    March 25, 2004
    Last Updated
    October 31, 2006
    Sponsor
    Kos Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00080275
    Brief Title
    Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
    Official Title
    An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (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 24 week 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 will take part in this study.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    Niacin, Statin, Zocor, Simvastatin, Coronary Heart Disease, Dyslipidemia, Atherosclerosis, Hypercholesterolemia, Stroke, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol, Lipoprotein, Lipid, Niacin ER/simvastatin, Total Cholesterol, Triglycerides

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    600 (false)

    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 a lipid modifying medication other than Zocor & he/she is willing to discontinue this medication LDL-C levels and/or non HDL-C levels above normal. Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study. 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
    18422390
    Citation
    Karas RH, Kashyap ML, Knopp RH, Keller LH, Bajorunas DR, Davidson MH. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs. 2008;8(2):69-81. doi: 10.2165/00129784-200808020-00001.
    Results Reference
    derived

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