Status:
COMPLETED
Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
Lead Sponsor:
Abbott
Conditions:
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 extende...
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 devi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00630877
Start Date
February 1 2008
End Date
June 1 2008
Last Update
October 9 2009
Active Locations (40)
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1
Birmingham, Alabama, United States, 35209
2
Anaheim, California, United States, 92801
3
Walnut Creek, California, United States, 94598
4
Denver, Colorado, United States, 80212