Back to resultsEvaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Niacin extended-release (NER)
Niacin extended-release (NER) placebo
Aspirin (ASA)
Aspirin (ASA) placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
NER/ASA
NER/ASA Placebo
NER Placebo/ASA Placebo
Arm Description
Outcomes
Primary Outcome Measures
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
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
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
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
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
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
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).
FAST Responsiveness--mean Flushing Severity Score
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.
FAST Responsiveness--maximum Flushing Severity Score
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.
Secondary Outcome Measures
Maximum Severity of Flushing Events Overall During the Study
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00630877
Brief Title
Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NER/ASA
Arm Type
Experimental
Arm Title
NER/ASA Placebo
Arm Type
Experimental
Arm Title
NER Placebo/ASA Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Niacin extended-release (NER)
Other Intervention Name(s)
ABT-919, Niaspan
Intervention Description
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
Intervention Type
Drug
Intervention Name(s)
Niacin extended-release (NER) placebo
Intervention Description
Tablets administered once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Aspirin (ASA)
Other Intervention Name(s)
acetylsalicylic acid
Intervention Description
Tablets (325 mg) administered once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Aspirin (ASA) placebo
Intervention Description
Tablets administered once daily for 6 weeks
Primary Outcome Measure Information:
Title
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
Description
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.
Time Frame
Week 1 to Week 2
Title
FAST Test-retest Reliability--maximum Flushing Severity Score
Description
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.
Time Frame
Week 1 to Week 2
Title
FAST Cross-sectional Construct Validity--mean Flushing Severity Score
Description
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.
Time Frame
Week 1
Title
FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
Description
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.
Time Frame
Week 1
Title
FAST Longitudinal Construct Validity--mean Flushing Severity Score
Description
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).
Time Frame
Week 1 to Week 2
Title
FAST Longitudinal Construct Validity--maximum Flushing Severity Score
Description
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).
Time Frame
Week 1 to Week 2
Title
FAST Responsiveness--mean Flushing Severity Score
Description
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.
Time Frame
Study start to Day 43
Title
FAST Responsiveness--maximum Flushing Severity Score
Description
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.
Time Frame
Study start to Day 43
Secondary Outcome Measure Information:
Title
Maximum Severity of Flushing Events Overall During the Study
Description
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.
Time Frame
Week 1 to Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roopal Thakkar, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66608
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19301936
Citation
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(4):215-29. doi: 10.2165/00044011-200929040-00001.
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Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
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