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

September 9, 2009 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • California
      • Anaheim, California, United States, 92801
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Denver, Colorado, United States, 80212
    • Florida
      • Brooksville, Florida, United States, 34613
      • Daytona Beach, Florida, United States, 32127
      • Hollywood, Florida, United States, 33023
      • Jacksonville, Florida, United States, 32216
      • Largo, Florida, United States, 33770
      • Miami, Florida, United States, 33126
      • Pembroke Pines, Florida, United States, 33026
    • Idaho
      • Boise, Idaho, United States, 83704
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Topeka, Kansas, United States, 66608
      • Wichita, Kansas, United States, 67207
      • Wichita, Kansas, United States, 67203
    • Missouri
      • St Louis, Missouri, United States, 63141
      • St. Louis, Missouri, United States, 63141
    • Nevada
      • Las Vegas, Nevada, United States, 89146
    • North Carolina
      • Durham, North Carolina, United States, 27704
      • High Point, North Carolina, United States, 27262
      • Salisbury, North Carolina, United States, 28144
      • Statesville, North Carolina, United States, 28677
    • Ohio
      • Cincinnati, Ohio, United States, 45242
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Harleysville, Pennsylvania, United States, 19438
      • Pittsburgh, Pennsylvania, United States, 15206
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Texas
      • Austin, Texas, United States, 78752
      • Carrollton, Texas, United States, 75006
      • Dallas, Texas, United States, 75251
      • San Antonio, Texas, United States, 78217
      • San Antonio, Texas, United States, 78224
    • Utah
      • Magna, Utah, United States, 84044
      • Murray, Utah, United States, 84107
      • Sandy, Utah, United States, 84094
    • Washington
      • Gig Harbor, Washington, United States, 98335
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NER/ASA
Drug: Niacin extended-release (NER)
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
Other Names:
  • Niaspan
  • ABT-919
Drug: Aspirin (ASA)
Tablets (325 mg) administered once daily for 6 weeks
Other Names:
  • acetylsalicylic acid
Experimental: NER/ASA Placebo
Drug: Niacin extended-release (NER)
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
Other Names:
  • Niaspan
  • ABT-919
Drug: Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks
Experimental: NER Placebo/ASA Placebo
Drug: Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks
Drug: Niacin extended-release (NER) placebo
Tablets administered once daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
Time Frame: 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.
Week 1 to Week 2
FAST Test-retest Reliability--maximum Flushing Severity Score
Time Frame: 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.
Week 1 to Week 2
FAST Cross-sectional Construct Validity--mean Flushing Severity Score
Time Frame: 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.
Week 1
FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
Time Frame: 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.
Week 1
FAST Longitudinal Construct Validity--mean Flushing Severity Score
Time Frame: 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).
Week 1 to Week 2
FAST Longitudinal Construct Validity--maximum Flushing Severity Score
Time Frame: 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).
Week 1 to Week 2
FAST Responsiveness--mean Flushing Severity Score
Time Frame: Study start to Day 43
The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Study start to Day 43
FAST Responsiveness--maximum Flushing Severity Score
Time Frame: Study start to Day 43
The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Study start to Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Severity of Flushing Events Overall During the Study
Time Frame: Week 1 to Week 6
The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.
Week 1 to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Roopal Thakkar, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2009

Last Update Submitted That Met QC Criteria

September 9, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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