Back to resultsStudy to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia (ASA EFFECTS)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
niacin extended-release (NER)
aspirin (ASA)
aspirin placebo (ASA Pbo)
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
NER 500; ASA run-in, ASA coadmin
NER 500; ASA Pbo run-in, ASA coadmin
NER 500; ASA Pbo run-in, ASA Pbo coadmin
NER 1000; ASA run-in, ASA coadmin
NER 1000; ASA Pbo run-in, ASA coadmin
NER 1000; ASA Pbo run-in, ASA Pbo coadmin
Arm Description
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)
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)
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)
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)
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)
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)
Outcomes
Primary Outcome Measures
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
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
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00626392
Brief Title
Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NER 500; ASA run-in, ASA coadmin
Arm Type
Experimental
Arm Description
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)
Arm Title
NER 500; ASA Pbo run-in, ASA coadmin
Arm Type
Experimental
Arm Description
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)
Arm Title
NER 500; ASA Pbo run-in, ASA Pbo coadmin
Arm Type
Experimental
Arm Description
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)
Arm Title
NER 1000; ASA run-in, ASA coadmin
Arm Type
Experimental
Arm Description
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)
Arm Title
NER 1000; ASA Pbo run-in, ASA coadmin
Arm Type
Experimental
Arm Description
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)
Arm Title
NER 1000; ASA Pbo run-in, ASA Pbo coadmin
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
niacin extended-release (NER)
Other Intervention Name(s)
Niaspan
Intervention Description
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
Intervention Type
Drug
Intervention Name(s)
aspirin (ASA)
Other Intervention Name(s)
acetylsalicylic acid
Intervention Description
325 mg tablets administered once daily
Intervention Type
Drug
Intervention Name(s)
aspirin placebo (ASA Pbo)
Other Intervention Name(s)
placebo
Intervention Description
Tablets administered once daily
Primary Outcome Measure Information:
Title
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
Description
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.
Time Frame
From Baseline to end of Week 1
Secondary Outcome Measure Information:
Title
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Description
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.
Time Frame
4 weeks
Title
Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Description
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.
Time Frame
4 weeks
Title
Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roopal Thakkar, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
City
Vista
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
N. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Penndel
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19331435
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.
Results Reference
result
Learn more about this trial
Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
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