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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

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.

Clinical Details

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 NiaspanŽ Plus Acetylsalicylic Acid (ASA), NiaspanŽ Plus ASA Placebo or NiaspanŽ 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.

Eligibility

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.

Locations and Contacts

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

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Murray, Utah 84107, United States

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Menomonee Falls, Wisconsin 53051, United States

Milwaukee, Wisconsin 53209, United States

Additional Information

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

Page last updated: August 23, 2015

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