Overview

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

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
Aspirin
Niacin
Niacinamide
Nicotinic Acids
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.