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

Abbott

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626392

M10-241

Details and patient eligibility

About

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.

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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277 participants in 6 patient groups

NER 500; ASA run-in, ASA coadmin

Experimental group

Description:

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)

Treatment:

Drug: aspirin (ASA)

Drug: niacin extended-release (NER)

NER 500; ASA Pbo run-in, ASA coadmin

Experimental group

Description:

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)

Treatment:

Drug: aspirin (ASA)

Drug: aspirin placebo (ASA Pbo)

Drug: niacin extended-release (NER)

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

Experimental group

Description:

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)

Treatment:

Drug: aspirin placebo (ASA Pbo)

Drug: niacin extended-release (NER)

NER 1000; ASA run-in, ASA coadmin

Experimental group

Description:

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)

Treatment:

Drug: aspirin (ASA)

Drug: niacin extended-release (NER)

NER 1000; ASA Pbo run-in, ASA coadmin

Experimental group

Description:

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)

Treatment:

Drug: aspirin (ASA)

Drug: aspirin placebo (ASA Pbo)

Drug: niacin extended-release (NER)

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

Experimental group

Description:

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)

Treatment:

Drug: aspirin placebo (ASA Pbo)

Drug: niacin extended-release (NER)