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

NCT00630877 | Completed Phase 3 Results

• 1 other identifier: M10-229
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 40

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (8)

• 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.

  Week 1 to Week 2

• 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.

  Week 1 to Week 2

• 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.

  Week 1

• 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.

  Week 1

• 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).

  Week 1 to Week 2

• 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).

  Week 1 to Week 2

• 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.

  Study start to Day 43

• 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.

  Study start to Day 43

Secondary Outcomes (1)

• Maximum Severity of Flushing Events Overall During the Study

  Week 1 to Week 6

Study Arms (3)

NER/ASA

EXPERIMENTAL

Drug: Niacin extended-release (NER); Drug: Aspirin (ASA)

NER/ASA Placebo

EXPERIMENTAL

Drug: Niacin extended-release (NER); Drug: Aspirin (ASA) placebo

NER Placebo/ASA Placebo

EXPERIMENTAL

Drug: Niacin extended-release (NER) placebo; Drug: Aspirin (ASA) placebo

Interventions

Niacin extended-release (NER) DRUG

Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg

Also known as: ABT-919, Niaspan

NER/ASA; NER/ASA Placebo

Niacin extended-release (NER) placebo DRUG

Tablets administered once daily for 6 weeks

NER Placebo/ASA Placebo

Aspirin (ASA) DRUG

Tablets (325 mg) administered once daily for 6 weeks

Also known as: acetylsalicylic acid

NER/ASA

Aspirin (ASA) placebo DRUG

Tablets administered once daily for 6 weeks

NER Placebo/ASA Placebo; NER/ASA Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (40)

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Birmingham, Alabama, 35209, United States

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Anaheim, California, 92801, United States

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Walnut Creek, California, 94598, United States

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Denver, Colorado, 80212, United States

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Brooksville, Florida, 34613, United States

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Daytona Beach, Florida, 32127, United States

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Hollywood, Florida, 33023, United States

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Jacksonville, Florida, 32216, United States

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Largo, Florida, 33770, United States

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Miami, Florida, 33126, United States

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Pembroke Pines, Florida, 33026, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60610, United States

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Arkansas City, Kansas, 67005, United States

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Topeka, Kansas, 66608, United States

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Wichita, Kansas, 67203, United States

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Wichita, Kansas, 67207, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89146, United States

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Durham, North Carolina, 27704, United States

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High Point, North Carolina, 27262, United States

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Salisbury, North Carolina, 28144, United States

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Statesville, North Carolina, 28677, United States

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Cincinnati, Ohio, 45242, United States

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Portland, Oregon, 97239, United States

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Duncansville, Pennsylvania, 16635, United States

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Harleysville, Pennsylvania, 19438, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Greer, South Carolina, 29651, United States

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Austin, Texas, 78752, United States

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Carrollton, Texas, 75006, United States

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Dallas, Texas, 75251, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78224, United States

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Magna, Utah, 84044, United States

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Murray, Utah, 84107, United States

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Sandy City, Utah, 84094, United States

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Gig Harbor, Washington, 98335, United States

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Menomonee Falls, Wisconsin, 53051, United States

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Milwaukee, Wisconsin, 53209, United States

Location

Related Publications (1)

• 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.

  PMID: 19301936 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

Niacin; Aspirin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

800-633-9110

Study Officials

• Roopal Thakkar, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 9, 2009
• Results First Posted: October 9, 2009

Record last verified: 2009-09

Locations

US (40)