Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
Condition: Dyslipidemia
MeSH terms: Dyslipidemias; Flushing
Intervention: Niacin extended-release (NER); Niacin extended-release (NER) placebo; Aspirin (ASA); Aspirin (ASA) placebo
Intervention description: Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg; Tablets administered once daily for 6 weeks; Tablets (325 mg) administered once daily for 6 weeks; Tablets administered once daily for 6 weeks
Intervention MeSH terms: Aspirin; Niacin; Niacinamide; Nicotinic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.