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

Phase 3

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: niacin extended-release (NER); Drug: aspirin (ASA); Drug: aspirin placebo (ASA Pbo)

• Registration Number: NCT00626392
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-29
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-16
• Results First Submitted QC: 2009-07-15
• Status Verified: 2009-08
• Results First Posted: 2009-08-25
• Last Update Submitted: 2009-08-26
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NER 1000; ASA Pbo run-in, ASA coadmin	aspirin placebo (ASA Pbo)	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)
NER 500; ASA Pbo run-in, ASA coadmin	aspirin (ASA)	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)
NER 1000; ASA Pbo run-in, ASA coadmin	aspirin (ASA)	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)
NER 1000; ASA Pbo run-in, ASA Pbo coadmin	aspirin placebo (ASA Pbo)	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)
NER 1000; ASA Pbo run-in, ASA Pbo coadmin	niacin extended-release (NER)	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)
NER 500; ASA run-in, ASA coadmin	niacin extended-release (NER)	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)
NER 500; ASA run-in, ASA coadmin	aspirin (ASA)	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)
NER 500; ASA Pbo run-in, ASA coadmin	niacin extended-release (NER)	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)
NER 1000; ASA run-in, ASA coadmin	niacin extended-release (NER)	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)
NER 1000; ASA run-in, ASA coadmin	aspirin (ASA)	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)
NER 500; ASA Pbo run-in, ASA coadmin	aspirin placebo (ASA Pbo)	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)
NER 500; ASA Pbo run-in, ASA Pbo coadmin	niacin extended-release (NER)	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)
NER 500; ASA Pbo run-in, ASA Pbo coadmin	aspirin placebo (ASA Pbo)	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)
NER 1000; ASA Pbo run-in, ASA coadmin	niacin extended-release (NER)	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)

Primary Outcome Measures

Name	Time	Method
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment	From Baseline to end of Week 1	The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.

Secondary Outcome Measures

Name	Time	Method
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment	4 weeks	The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment	4 weeks	Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.
Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment	4 weeks	Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.