We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626392
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : August 25, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE February 21, 2008
First Posted Date  ICMJE February 29, 2008
Results First Submitted Date  ICMJE April 16, 2009
Results First Posted Date  ICMJE August 25, 2009
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE February 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2008)
The maximum severity of flushing events subjects experience [ Time Frame: 5 wks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
  • Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2008)
To assess the efficacy and safety of Niaspan and ASA [ Time Frame: 5 wks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemia
Intervention  ICMJE
  • Drug: niacin extended-release (NER)
    Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
    Other Name: Niaspan
  • Drug: aspirin (ASA)
    325 mg tablets administered once daily
    Other Name: acetylsalicylic acid
  • Drug: aspirin placebo (ASA Pbo)
    Tablets administered once daily
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: NER 500; ASA run-in, ASA coadmin
    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)
    Interventions:
    • Drug: niacin extended-release (NER)
    • Drug: aspirin (ASA)
  • Experimental: NER 500; ASA Pbo run-in, ASA coadmin
    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)
    Interventions:
    • Drug: niacin extended-release (NER)
    • Drug: aspirin (ASA)
    • Drug: aspirin placebo (ASA Pbo)
  • Experimental: NER 500; ASA Pbo run-in, ASA Pbo coadmin
    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)
    Interventions:
    • Drug: niacin extended-release (NER)
    • Drug: aspirin placebo (ASA Pbo)
  • Experimental: NER 1000; ASA run-in, ASA coadmin
    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)
    Interventions:
    • Drug: niacin extended-release (NER)
    • Drug: aspirin (ASA)
  • Experimental: NER 1000; ASA Pbo run-in, ASA coadmin
    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)
    Interventions:
    • Drug: niacin extended-release (NER)
    • Drug: aspirin (ASA)
    • Drug: aspirin placebo (ASA Pbo)
  • Experimental: NER 1000; ASA Pbo run-in, ASA Pbo coadmin
    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)
    Interventions:
    • Drug: niacin extended-release (NER)
    • Drug: aspirin placebo (ASA Pbo)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2009)
277
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2008)
275
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00626392
Other Study ID Numbers  ICMJE M10-241
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Scott Krause, Associate Director, Abbott
Original Responsible Party Scott Krause, Assistant Director, Abbott
Current Study Sponsor  ICMJE Abbott
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roopal Thakkar, MD Abbott
PRS Account Abbott
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP