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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00626392
First received: February 21, 2008
Last updated: August 26, 2009
Last verified: August 2009
History of Changes
Results First Received: April 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dyslipidemia
Interventions: Drug: niacin extended-release (NER)
Drug: aspirin (ASA)
Drug: aspirin placebo (ASA Pbo)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 47 study sites in the United States between February and April, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study had a 1-week run-in (acetylsalicylic acid [ASA] 325 mg or ASA placebo [Pbo] once daily) prior to 4 weeks of niacin extended-release (NER) plus ASA/ASA Pbo coadministration. Ten of 277 randomized subjects discontinued before run-in due to withdrawal of consent (4), lost to follow-up (4), protocol violation (1), and other (1).

Reporting Groups
  Description
NER 500; ASA run-in, ASA Coadmin Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
NER 500; ASA Pbo run-in, ASA Coadmin Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
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 (4 weeks)
NER 1000; ASA run-in; ASA Coadmin Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
NER 1000; ASA Pbo run-in, ASA Coadmin Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
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 (4 weeks)

Participant Flow for 2 periods

 Period 1:   Run-in Period
    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  
STARTED     45     44     44     44     45     45  
COMPLETED     44     43     41     43     41     44  
NOT COMPLETED     1     1     3     1     4     1  
Adverse Event                 0                 0                 1                 0                 1                 0  
Withdrawal by Subject                 0                 1                 1                 1                 3                 1  
Noncompliance                 1                 0                 1                 0                 0                 0  

Period 2:   Coadministration Period
    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  
STARTED     44     43     41     43     41     44  
COMPLETED     40     38     31     36     36     38  
NOT COMPLETED     4     5     10     7     5     6  
Adverse Event                 3                 1                 7                 4                 3                 4  
Withdrawal by Subject                 1                 1                 0                 1                 0                 1  
Protocol Violation                 0                 1                 0                 1                 1                 0  
Other                 0                 2                 3                 1                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
NER 500; ASA run-in, ASA Coadmin Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
NER 500; ASA Pbo run-in, ASA Coadmin Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
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 (4 weeks)
NER 1000; ASA run-in, ASA Coadmin Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
NER 1000; ASA Pbo run-in, ASA Coadmin Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
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 (4 weeks)
Total Total of all reporting groups

Baseline Measures
    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     Total  
Number of Participants  
[units: participants]
 		  44     43     41     43     41     44     256  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  55.5  ± 10.62     49.0  ± 10.48     51.5  ± 12.58     53.7  ± 12.4     54.8  ± 11.08     52.3  ± 12.45     52.8  ± 11.73  
Gender [1]
[units: participants]
 		             
Female     21     23     21     15     21     23     124  
Male     23     20     20     28     20     21     132  
Region of Enrollment [1]
[units: participants]
 		             
United States     44     43     41     43     41     44     256  
[1] Includes only those subjects who entered the coadministration period and received at least one dose of study medication.



  Outcome Measures
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1.  Primary:   Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment   [ Time Frame: From Baseline to end of Week 1 ]
  Show Outcome Measure 1

2.  Secondary:   Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment   [ Time Frame: 4 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment   [ Time Frame: 4 weeks ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
  Show Outcome Measure 4


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Any Acetylsalicylic Acid Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
No Acetylsalicylic Acid Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.

Serious Adverse Events
    Any Acetylsalicylic Acid     No Acetylsalicylic Acid  
Total, serious adverse events      
# participants affected     1     1  
Gastrointestinal disorders      
Esophageal ulcer * 1    
# participants affected / at risk     0/171 (0.00%)     1/85 (1.18%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Dyspnea * 1    
# participants affected / at risk     1/171 (0.58%)     0/85 (0.00%)  
# events     1     0  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 10.1




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Information Specialist
Organization: Abbott
phone: 800-633-9110


Publications of Results:


Responsible Party: Scott Krause, Associate Director, Abbott
ClinicalTrials.gov Identifier: NCT00626392     History of Changes
Other Study ID Numbers: M10-241
Study First Received: February 21, 2008
Results First Received: April 16, 2009
Last Updated: August 26, 2009
Health Authority: United States: Food and Drug Administration