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

Dyslipidemia Clinical Trial

— ASA EFFECTS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626392
• Other study ID #: M10-241
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2008
• Last updated: August 26, 2009
• Start date: February 2008
• Est. completion date: April 2008

Study information

• Verified date: August 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
• aspirin (ASA)
325 mg tablets administered once daily
• aspirin placebo (ASA Pbo)
Tablets administered once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.2165/00129784-200909020-00001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment		From Baseline to end of Week 1	No
Secondary	Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment		4 weeks	No
Secondary	Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment		4 weeks	No
Secondary	Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment		4 weeks	No