Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia

NCT00626392 | Completed Phase 3 Results

• 1 other identifier: M10-241
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 26

Brief Summary

The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment

  The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.

  From Baseline to end of Week 1

Secondary Outcomes (3)

• Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

  4 weeks

• Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

  4 weeks

• Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

  4 weeks

Study Arms (6)

NER 500; ASA run-in, ASA coadmin

EXPERIMENTAL

Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks)

Drug: niacin extended-release (NER); Drug: aspirin (ASA)

NER 500; ASA Pbo run-in, ASA coadmin

EXPERIMENTAL

Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks)

Drug: niacin extended-release (NER); Drug: aspirin (ASA); Drug: aspirin placebo (ASA Pbo)

NER 500; ASA Pbo run-in, ASA Pbo coadmin

EXPERIMENTAL

Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks)

Drug: niacin extended-release (NER); Drug: aspirin placebo (ASA Pbo)

NER 1000; ASA run-in, ASA coadmin

EXPERIMENTAL

Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks)

Drug: niacin extended-release (NER); Drug: aspirin (ASA)

NER 1000; ASA Pbo run-in, ASA coadmin

EXPERIMENTAL

Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks)

Drug: niacin extended-release (NER); Drug: aspirin (ASA); Drug: aspirin placebo (ASA Pbo)

NER 1000; ASA Pbo run-in, ASA Pbo coadmin

EXPERIMENTAL

Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks)

Drug: niacin extended-release (NER); Drug: aspirin placebo (ASA Pbo)

Interventions

niacin extended-release (NER) DRUG

Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period

Also known as: Niaspan

NER 1000; ASA Pbo run-in, ASA Pbo coadmin; NER 1000; ASA Pbo run-in, ASA coadmin; NER 1000; ASA run-in, ASA coadmin; NER 500; ASA Pbo run-in, ASA Pbo coadmin; NER 500; ASA Pbo run-in, ASA coadmin; NER 500; ASA run-in, ASA coadmin

aspirin (ASA) DRUG

325 mg tablets administered once daily

Also known as: acetylsalicylic acid

NER 1000; ASA Pbo run-in, ASA coadmin; NER 1000; ASA run-in, ASA coadmin; NER 500; ASA Pbo run-in, ASA coadmin; NER 500; ASA run-in, ASA coadmin

aspirin placebo (ASA Pbo) DRUG

Tablets administered once daily

Also known as: placebo

NER 1000; ASA Pbo run-in, ASA Pbo coadmin; NER 1000; ASA Pbo run-in, ASA coadmin; NER 500; ASA Pbo run-in, ASA Pbo coadmin; NER 500; ASA Pbo run-in, ASA coadmin

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 (26)

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

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Scottsdale, Arizona, 85251, United States

Location

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Tucson, Arizona, 85710, United States

Location

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Tucson, Arizona, 85712, United States

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Anaheim, California, 92801, United States

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Los Angeles, California, 90057, United States

Location

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Newport Beach, California, 92660, United States

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Stockton, California, 95204, United States

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Vista, California, 90057, United States

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Westlake Village, California, 91361, United States

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Coral Gables, Florida, 33134, United States

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Jacksonville, Florida, 32259, United States

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Miami, Florida, 33186, United States

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Pembroke Pines, Florida, 33027, United States

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West Palm Beach, Florida, 33407, United States

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North Dartmouth, Massachusetts, 02747, United States

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Rochester, New York, 14609, United States

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Charlotte, North Carolina, 28262, United States

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Winston-Salem, North Carolina, 27103, United States

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Penndel, Pennsylvania, 19047, United States

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Johnston, Rhode Island, 02919, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Simpsonville, South Carolina, 29681, United States

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Colleyville, Texas, 76034, United States

Location

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Houston, Texas, 77074, United States

Location

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San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, Padley RJ. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.

  PMID: 19331435 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 21, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 2, 2009
• Results First Posted: August 25, 2009

Record last verified: 2009-08

Locations

US (26)