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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630877
• Other study ID #: M10-229
• Status: Completed
• Phase: Phase 3
• First received: February 29, 2008
• Last updated: September 9, 2009
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: September 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Niacin extended-release (NER)
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
• Niacin extended-release (NER) placebo
Tablets administered once daily for 6 weeks
• Aspirin (ASA)
Tablets (325 mg) administered once daily for 6 weeks
• Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kawata AK, Revicki DA, Thakkar R, Jiang P, Krause S, Davidson MH, Punzi HA, Padley RJ. Flushing ASsessment Tool (FAST): psychometric properties of a new measure assessing flushing symptoms and clinical impact of niacin therapy. Clin Drug Investig. 2009;29 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score		Week 1 to Week 2	No
Primary	FAST Test-retest Reliability--maximum Flushing Severity Score		Week 1 to Week 2	No
Primary	FAST Cross-sectional Construct Validity--mean Flushing Severity Score		Week 1	No
Primary	FAST Cross-sectional Construct Validity--maximum Flushing Severity Score		Week 1	No
Primary	FAST Longitudinal Construct Validity--mean Flushing Severity Score		Week 1 to Week 2	No
Primary	FAST Longitudinal Construct Validity--maximum Flushing Severity Score		Week 1 to Week 2	No
Primary	FAST Responsiveness--mean Flushing Severity Score		Study start to Day 43	No
Primary	FAST Responsiveness--maximum Flushing Severity Score		Study start to Day 43	No
Secondary	Maximum Severity of Flushing Events Overall During the Study		Week 1 to Week 6	No