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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00630877
First received: February 29, 2008
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: Niacin extended-release (NER)
Drug: Niacin extended-release (NER) placebo
Drug: Aspirin (ASA)
Drug: Aspirin (ASA) placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score [ Time Frame: Week 1 to Week 2 ] [ Designated as safety issue: No ]
  • FAST Test-retest Reliability--maximum Flushing Severity Score [ Time Frame: Week 1 to Week 2 ] [ Designated as safety issue: No ]
  • FAST Cross-sectional Construct Validity--mean Flushing Severity Score [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • FAST Cross-sectional Construct Validity--maximum Flushing Severity Score [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • FAST Longitudinal Construct Validity--mean Flushing Severity Score [ Time Frame: Week 1 to Week 2 ] [ Designated as safety issue: No ]
  • FAST Longitudinal Construct Validity--maximum Flushing Severity Score [ Time Frame: Week 1 to Week 2 ] [ Designated as safety issue: No ]
  • FAST Responsiveness--mean Flushing Severity Score [ Time Frame: Study start to Day 43 ] [ Designated as safety issue: No ]
  • FAST Responsiveness--maximum Flushing Severity Score [ Time Frame: Study start to Day 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum Severity of Flushing Events Overall During the Study [ Time Frame: Week 1 to Week 6 ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • ABT-919
  • Niaspan
Drug: Aspirin (ASA)
Tablets (325 mg) administered once daily for 6 weeks
Other Name: 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:
  • ABT-919
  • Niaspan
Drug: Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks
Experimental: NER Placebo/ASA Placebo Drug: Niacin extended-release (NER) placebo
Tablets administered once daily for 6 weeks
Drug: Aspirin (ASA) placebo
Tablets administered once daily for 6 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00630877

  Show 41 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Roopal Thakkar, MD Abbott
  More Information

Additional Information:
Publications:
Responsible Party: Scott Krause, Associate Director, Clinical Research, Abbott
ClinicalTrials.gov Identifier: NCT00630877     History of Changes
Other Study ID Numbers: M10-229
Study First Received: February 29, 2008
Results First Received: June 11, 2009
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Aspirin
Niacin
Nicotinic Acids
Niacinamide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 16, 2014