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

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ClinicalTrials.gov Identifier: NCT00630877
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : October 9, 2009
Last Update Posted : October 9, 2009
Sponsor:
Information provided by:
Abbott

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


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:
  • 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




Primary Outcome Measures :
  1. Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score [ Time Frame: Week 1 to Week 2 ]
  2. FAST Test-retest Reliability--maximum Flushing Severity Score [ Time Frame: Week 1 to Week 2 ]
  3. FAST Cross-sectional Construct Validity--mean Flushing Severity Score [ Time Frame: Week 1 ]
  4. FAST Cross-sectional Construct Validity--maximum Flushing Severity Score [ Time Frame: Week 1 ]
  5. FAST Longitudinal Construct Validity--mean Flushing Severity Score [ Time Frame: Week 1 to Week 2 ]
  6. FAST Longitudinal Construct Validity--maximum Flushing Severity Score [ Time Frame: Week 1 to Week 2 ]
  7. FAST Responsiveness--mean Flushing Severity Score [ Time Frame: Study start to Day 43 ]
  8. FAST Responsiveness--maximum Flushing Severity Score [ Time Frame: Study start to Day 43 ]

Secondary Outcome Measures :
  1. Maximum Severity of Flushing Events Overall During the Study [ Time Frame: Week 1 to Week 6 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630877


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35209
United States, California
Anaheim, California, United States, 92801
Walnut Creek, California, United States, 94598
United States, Colorado
Denver, Colorado, United States, 80212
United States, 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
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60610
United States, Kansas
Arkansas City, Kansas, United States, 67005
Topeka, Kansas, United States, 66608
Wichita, Kansas, United States, 67203
Wichita, Kansas, United States, 67207
United States, Missouri
St Louis, Missouri, United States, 63141
St. Louis, Missouri, United States, 63141
United States, Nevada
Las Vegas, Nevada, United States, 89146
United States, 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
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Harleysville, Pennsylvania, United States, 19438
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, 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
United States, Utah
Magna, Utah, United States, 84044
Murray, Utah, United States, 84107
Sandy, Utah, United States, 84094
United States, Washington
Gig Harbor, Washington, United States, 98335
United States, Wisconsin
Menomonee Falls, Wisconsin, United States, 53051
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Roopal Thakkar, MD Abbott

Publications of Results:
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Responsible Party: Scott Krause, Associate Director, Clinical Research, Abbott
ClinicalTrials.gov Identifier: NCT00630877    
Other Study ID Numbers: M10-229
First Posted: March 7, 2008    Key Record Dates
Results First Posted: October 9, 2009
Last Update Posted: October 9, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Dyslipidemias
Flushing
Lipid Metabolism Disorders
Metabolic Diseases
Skin Manifestations
Signs and Symptoms
Aspirin
Niacin
Niacinamide
Nicotinic Acids
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex