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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia

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

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Roopal Thakkar, MD, Study Director, Affiliation: Abbott

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment

Secondary outcome:

Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Huntsville, Alabama 35801, United States

Scottsdale, Arizona 85251, United States

Tucson, Arizona 85710, United States

Tucson, Arizona 85712, United States

Anaheim, California 92801, United States

Los Angeles, California 90057, United States

Newport Beach, California 92660, United States

Stockton, California 95204, United States

Vista, California 90057, United States

Westlake Village, California 91361, United States

Coral Gables, Florida 33134, United States

Jacksonville, Florida 32259, United States

Miami, Florida 33186, United States

Pembroke Pines, Florida 33027, United States

West Palm Beach, Florida 33407, United States

N. Dartmouth, Massachusetts 02747, United States

Rochester, New York 14609, United States

Charlotte, North Carolina 28262, United States

Winston-Salem, North Carolina 27103, United States

Penndel, Pennsylvania 19047, United States

Johnston, Rhode Island 02919, United States

Mt. Pleasant, South Carolina 29464, United States

Simpsonville, South Carolina 29681, United States

Colleyville, Texas 76034, United States

Houston, Texas 77074, United States

San Antonio, Texas 78229, United States

Additional Information

Starting date: February 2008
Last updated: August 26, 2009

Page last updated: August 23, 2015

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