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:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00626392
First received: February 21, 2008
Last updated: August 26, 2009
Last verified: August 2009
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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
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:
|
Aspirin Flushing Dyslipidemias Signs and Symptoms Lipid Metabolism Disorders Metabolic Diseases Niacin Nicotinic Acids 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 Vasodilator Agents Hypolipidemic Agents |
ClinicalTrials.gov processed this record on May 23, 2013