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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00626392
First received: February 21, 2008
Last updated: August 26, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Dyslipidemia
Drug: niacin extended-release (NER)
Drug: aspirin (ASA)
Drug: aspirin placebo (ASA Pbo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment [ Time Frame: From Baseline to end of Week 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 277
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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: NCT00626392

Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85712
Tucson, Arizona, United States, 85710
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
Study Director: Roopal Thakkar, MD Abbott
  More Information

Publications:
Responsible Party: Scott Krause, Associate Director, Abbott
ClinicalTrials.gov Identifier: NCT00626392     History of Changes
Other Study ID Numbers: M10-241
Study First Received: February 21, 2008
Results First Received: April 16, 2009
Last Updated: August 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Aspirin
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

ClinicalTrials.gov processed this record on September 16, 2014