Clinical trial NCT00626392: Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
timeFrame: From Baseline to end of Week 1
Secondary outcomes:
measure: Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
timeFrame: 4 weeks
measure: Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
timeFrame: 4 weeks
measure: Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Stockton
country: United States
state: California
city: Vista
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: N. Dartmouth
country: United States
state: Massachusetts
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Penndel
country: United States
state: Pennsylvania
city: Johnston
country: United States
state: Rhode Island
city: Mt. Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Colleyville
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Abbott
name: Roopal Thakkar, MD
role: STUDY_DIRECTOR
References:
citation: Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, Padley RJ. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.