An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

Study Identifier
019-05-06-CR
CT.gov Identifier
NCT00465088
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dyslipidemia
    • Study Drug
  • Niacin ER/Simvastatin Tablets
  • atorvastatin
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    21+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subjects must meet all of the following laboratory criteria: - HDL-C <40 mg/dL for men and <50 mg/dL for women. - LDL-C ≥130 mg/dL but <250 mg/dL. - TG <350 mg/dL. - Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN). - Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT] < 1.3 x ULN. - Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).
    Exclusion Criteria:
    - Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion

    Protocol Summary

    To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin

    (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating

    effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are

    currently off lipid-modifying therapy. This was a prospective, randomized, open-label,

    blinded endpoint (PROBE) study.

    Study Locations

    Location
    Status
    Location
    Anaheim, California, United States, 92801
    Status
    Not applicable
    Location
    Huntington Park, California, United States, 90255
    Status
    Not applicable
    Location
    Long Beach, California, United States, 90822
    Status
    Not applicable
    Location
    Sacramento, California, United States, 95825
    Status
    Not applicable
    Location
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
    Location
    Brooksville, Florida, United States, 34613
    Status
    Not applicable
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