Who is sponsoring NCT00630877?

NCT00630877 is sponsored by Abbott.

What condition does NCT00630877 study?

NCT00630877 studies Dyslipidemia.

What drugs are being tested in NCT00630877?

Interventions: Niacin extended-release (NER), Niacin extended-release (NER) placebo, Aspirin (ASA), Aspirin (ASA) placebo.

What is the status of NCT00630877?

NCT00630877 is currently COMPLETED.

Last reviewed 2009-09-09 · How we verify

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

NCT00630877 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	276
Start date	2008-02
Completion	2008-06

Conditions

Dyslipidemia

Interventions

Niacin extended-release (NER)
Niacin extended-release (NER) placebo
Aspirin (ASA)
Aspirin (ASA) placebo

Primary outcomes

Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score — Week 1 to Week 2
Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
FAST Test-retest Reliability--maximum Flushing Severity Score — Week 1 to Week 2
Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
FAST Cross-sectional Construct Validity--mean Flushing Severity Score — Week 1
The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
FAST Cross-sectional Construct Validity--maximum Flushing Severity Score — Week 1
The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
FAST Longitudinal Construct Validity--mean Flushing Severity Score — Week 1 to Week 2
The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
FAST Longitudinal Construct Validity--maximum Flushing Severity Score — Week 1 to Week 2
The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).

Countries

United States