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 ScoreFAST 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.
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Additional Information
Starting date: February 2008
Last updated: September 9, 2009
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