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

Condition(s) targeted: Dyslipidemia

Intervention: Niacin extended-release (NER) (Drug); Niacin extended-release (NER) placebo (Drug); Aspirin (ASA) (Drug); Aspirin (ASA) placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Roopal Thakkar, MD, Study Director, Affiliation: Abbott

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.

Official title: A Randomized, Double-blind, Parallel, Multicenter, Placebo-controlled, Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus ASA Placebo Daily for Six Weeks

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score

FAST Test-retest Reliability--maximum Flushing Severity Score

FAST Cross-sectional Construct Validity--mean Flushing Severity Score

FAST Cross-sectional Construct Validity--maximum Flushing Severity Score

FAST Longitudinal Construct Validity--mean Flushing Severity Score

FAST Longitudinal Construct Validity--maximum Flushing Severity Score

FAST Responsiveness--mean Flushing Severity Score

FAST Responsiveness--maximum Flushing Severity Score

Secondary outcome: Maximum Severity of Flushing Events Overall During the Study

Detailed description: This study was designed to evaluate the psychometric characteristics of the FAST questionnaire. The FAST is a self-administered questionnaire, completed using a hand-held electronic data capture device (LogPad e-diary). Subjects recorded the start and stop date and time of each flushing event, the presence and severity of individual flushing symptoms (redness, warmth, tingling and/or itching), and an overall assessment of their flushing experience. Evaluation of the psychometric characteristics of the FAST was based on 3 primary data analyses: 1 ) test-retest reliability based on the intraclass correlation coefficient; 2) construct validity based on Spearman correlation coefficients; and 3) responsiveness based on changes in FAST scores. The mean and maximum severity of flushing events, as measured by the FAST, were the primary variables evaluated in each of the 3 data analyses mentioned above. Psychometric analyses were performed blinded to treatment group assignment.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Birmingham, Alabama 35209, United States

Anaheim, California 92801, United States

Walnut Creek, California 94598, United States

Denver, Colorado 80212, United States

Brooksville, Florida 34613, United States

Daytona Beach, Florida 32127, United States

Hollywood, Florida 33023, United States

Jacksonville, Florida 32216, United States

Largo, Florida 33770, United States

Miami, Florida 33126, United States

Pembroke Pines, Florida 33026, United States

Boise, Idaho 83704, United States

Chicago, Illinois 60610, United States

Arkansas City, Kansas 67005, United States

Topeka, Kansas 66608, United States

Wichita, Kansas 67203, United States

Wichita, Kansas 67207, United States

St Louis, Missouri 63141, United States

St. Louis, Missouri 63141, United States

Las Vegas, Nevada 89146, United States

Durham, North Carolina 27704, United States

High Point, North Carolina 27262, United States

Salisbury, North Carolina 28144, United States

Statesville, North Carolina 28677, United States

Cincinnati, Ohio 45242, United States

Portland, Oregon 97239, United States

Duncansville, Pennsylvania 16635, United States

Harleysville, Pennsylvania 19438, United States

Pittsburgh, Pennsylvania 15206, United States

Greer, South Carolina 29651, United States

Austin, Texas 78752, United States

Carrollton, Texas 75006, United States

Dallas, Texas 75251, United States

San Antonio, Texas 78224, United States

San Antonio, Texas 78217, United States

Magna, Utah 84044, United States

Murray, Utah 84107, United States

Sandy, Utah 84094, United States

Gig Harbor, Washington 98335, United States

Menomonee Falls, Wisconsin 53051, United States

Milwaukee, Wisconsin 53209, United States

Starting date: February 2008
Last updated: September 9, 2009