Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin

Study Identifier
M10-229
CT.gov Identifier
NCT00630877
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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 extended-release (NER)
  • Niacin extended-release (NER) placebo
  • Aspirin (ASA)
  • Aspirin (ASA) placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject must be 18 years of age or older. - If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study. - Have dyslipidemia as demonstrated by laboratory results.
    Exclusion Criteria:
    - Have glycosylated hemoglobin (HbA1c) >= 9.0%. - Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] < 30 mL/minute, as calculated from creatinine clearance). - Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit. - Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit. - Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit. - Have symptomatic heart failure defined as dyspnea at rest or with exertion (mild peripheral edema is not exclusionary). - Have a systolic blood pressure measurement of > 180 mmHg or a diastolic blood pressure measurement of > 110 mmHg at the Screening or Baseline Visit - Have active gout or uric acid >= 11 mg/dL. - Have a history of hepatitis (acute or chronic), obstructive liver disease, or alanine aminotransferase (ALT; serum glutamic pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase [SGOT]) values >= 1.3 times the upper limit of normal (ULN) at the Screening Visit. - Have creatine phosphokinase (CPK) >= 3 x ULN at the Screening Visit. - Have used an investigational study drug or participated in an investigational study within 30 days of the Screening Visit. - Have a health condition or laboratory abnormality (inclusive of clinically significant laboratory results at Screening Visit), which, in the opinion of the Investigator, may be adversely affected by the procedures or study medications in this study.

    Protocol Summary

    The primary purpose of this study was to evaluate the psychometric characteristics

    (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects

    receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.

    The FAST is a questionnaire that was developed to provide a detailed assessment of flushing

    symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on

    flushing symptoms, as measured by the FAST, was also evaluated.

    Study Locations

    Location
    Status
    Location
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    Anaheim, California, United States, 92801
    Status
    Not applicable
    Location
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
    Location
    Denver, Colorado, United States, 80212
    Status
    Not applicable
    Location
    Brooksville, Florida, United States, 34613
    Status
    Not applicable
    Location
    Daytona Beach, Florida, United States, 32127
    Status
    Not applicable
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