NCT00630877

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Niacin extended-release (NER)	Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
DRUG	Niacin extended-release (NER) placebo	Tablets administered once daily for 6 weeks
DRUG	Aspirin (ASA)	Tablets (325 mg) administered once daily for 6 weeks
DRUG	Aspirin (ASA) placebo	Tablets administered once daily for 6 weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-03-07
• Last updated: 2009-10-09
• Results posted: 2009-10-09

Locations

40 sites across 1 country: United States