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

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ClinicalTrials.gov Identifier: NCT00626392
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : August 25, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Abbott

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: niacin extended-release (NER) Drug: aspirin (ASA) Drug: aspirin placebo (ASA Pbo) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Study Start Date : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NER 500; ASA run-in, ASA coadmin
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)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Other Name: Niaspan

Drug: aspirin (ASA)
325 mg tablets administered once daily
Other Name: acetylsalicylic acid
Experimental: NER 500; ASA Pbo run-in, ASA coadmin
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)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Other Name: Niaspan

Drug: aspirin (ASA)
325 mg tablets administered once daily
Other Name: acetylsalicylic acid

Drug: aspirin placebo (ASA Pbo)
Tablets administered once daily
Other Name: placebo
Experimental: NER 500; ASA Pbo run-in, ASA Pbo coadmin
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)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Other Name: Niaspan

Drug: aspirin placebo (ASA Pbo)
Tablets administered once daily
Other Name: placebo
Experimental: NER 1000; ASA run-in, ASA coadmin
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)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Other Name: Niaspan

Drug: aspirin (ASA)
325 mg tablets administered once daily
Other Name: acetylsalicylic acid
Experimental: NER 1000; ASA Pbo run-in, ASA coadmin
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)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Other Name: Niaspan

Drug: aspirin (ASA)
325 mg tablets administered once daily
Other Name: acetylsalicylic acid

Drug: aspirin placebo (ASA Pbo)
Tablets administered once daily
Other Name: placebo
Experimental: NER 1000; ASA Pbo run-in, ASA Pbo coadmin
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)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Other Name: Niaspan

Drug: aspirin placebo (ASA Pbo)
Tablets administered once daily
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment [ Time Frame: From Baseline to end of Week 1 ]
    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.


Secondary Outcome Measures :
  1. Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment [ Time Frame: 4 weeks ]
    The maximum severity of flushing events subjects experienced during 4 weeks 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.

  2. Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment [ Time Frame: 4 weeks ]
    Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.

  3. Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment [ Time Frame: 4 weeks ]
    Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.


Eligibility Criteria
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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.
Contacts and Locations
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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): NCT00626392


Locations
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United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85710
Tucson, Arizona, United States, 85712
United States, California
Anaheim, California, United States, 92801
Los Angeles, California, United States, 90057
Newport Beach, California, United States, 92660
Stockton, California, United States, 95204
Vista, California, United States, 90057
Westlake Village, California, United States, 91361
United States, Florida
Coral Gables, Florida, United States, 33134
Jacksonville, Florida, United States, 32259
Miami, Florida, United States, 33186
Pembroke Pines, Florida, United States, 33027
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
N. Dartmouth, Massachusetts, United States, 02747
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Charlotte, North Carolina, United States, 28262
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Penndel, Pennsylvania, United States, 19047
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
Simpsonville, South Carolina, United States, 29681
United States, Texas
Colleyville, Texas, United States, 76034
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Roopal Thakkar, MD Abbott
More Information
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Publications of Results:

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Responsible Party: Scott Krause, Associate Director, Abbott
ClinicalTrials.gov Identifier: NCT00626392    
Other Study ID Numbers: M10-241
First Posted: February 29, 2008    Key Record Dates
Results First Posted: August 25, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Dyslipidemias
Flushing
Lipid Metabolism Disorders
Metabolic Diseases
Skin Manifestations
Aspirin
Niacin
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
Vitamins
Micronutrients