Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
NCT ID: NCT00630877
Last Updated: 2009-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2008-02-29
2008-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NER/ASA
Niacin extended-release (NER)
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
Aspirin (ASA)
Tablets (325 mg) administered once daily for 6 weeks
NER/ASA Placebo
Niacin extended-release (NER)
Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo
Tablets administered once daily for 6 weeks
Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Roopal Thakkar, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Birmingham, Alabama, United States
Anaheim, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Brooksville, Florida, United States
Daytona Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Arkansas City, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Durham, North Carolina, United States
High Point, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greer, South Carolina, United States
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Magna, Utah, United States
Murray, Utah, United States
Sandy City, Utah, United States
Gig Harbor, Washington, United States
Menomonee Falls, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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M10-229
Identifier Type: -
Identifier Source: org_study_id
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