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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Aspirin; Niacin; Niacinamide; Nicotinic Acids

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.