Phase 3 Completed N=271 Randomized Quadruple-blind Treatment

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

Dyslipidemia

Source: ClinicalTrials.gov NCT00630877 ↗

Enrolled (actual)

271

Serious AEs

—

Results posted

Oct 2009

Primary outcomePrimary: Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score — 0.75 Intraclass correlation coefficient

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score	0.75	—
PRIMARY FAST Test-retest Reliability--maximum Flushing Severity Score	0.40	—
PRIMARY FAST Cross-sectional Construct Validity--mean Flushing Severity Score	0.64	<0.0001 sig
PRIMARY FAST Cross-sectional Construct Validity--maximum Flushing Severity Score	0.66	<0.0001 sig
PRIMARY FAST Longitudinal Construct Validity--mean Flushing Severity Score	-0.44	<0.0001 sig
PRIMARY FAST Longitudinal Construct Validity--maximum Flushing Severity Score	-0.42	<0.0001 sig
PRIMARY FAST Responsiveness--mean Flushing Severity Score	-0.51; 0.15	0.002 sig
PRIMARY FAST Responsiveness--maximum Flushing Severity Score	-1.85; -0.18	<0.001 sig
SECONDARY Maximum Severity of Flushing Events Overall During the Study	26; 14; 37; 23; 16; 38	<0.001 sig

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] 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.

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Data sourced from ClinicalTrials.gov (NCT00630877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.