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Alternative Options to Minimize Niacin-Induced Flushing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00895193
First received: May 6, 2009
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Hypercholesterolemia
Flushing
Interventions: Other: Apple pectin
Drug: Aspirin 325 mg
Other: Placebo

  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
Initial screening occurred over the telephone. Subjects that met preliminary study criteria were scheduled for a screening visit. Recruitment was conducted at the University of Kansas Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Apple-pectin 2000mg Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Participant Flow:   Overall Study
    Apple-pectin 2000mg   Regular Non-enteric Coated Aspirin 325mg   Apple Pectin + Aspirin   Placebo Comparator
STARTED   25   25   25   25 
COMPLETED   25   25   25   25 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Apple-pectin 2000mg Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Total Total of all reporting groups

Baseline Measures
   Apple-pectin 2000mg   Regular Non-enteric Coated Aspirin 325mg   Apple Pectin + Aspirin   Placebo Comparator   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   25   25   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (11.5)   40  (13.3)   40  (12.3)   38  (12.7)   38.2  (12.5) 
Gender 
[Units: Participants]
         
Female   11   12   11   11   45 
Male   14   13   14   14   55 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   4   9   5   5   23 
White   16   15   20   20   71 
More than one race   0   0   0   0   0 
Unknown or Not Reported   5   1   0   0   6 
Region of Enrollment 
[Units: Participants]
         
United States   25   25   25   25   100 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 26  (5.5)   27  (6.2)   26  (5.3)   26  (5.0)   26.4  (5.4) 
Waist Circumference 
[Units: Inches]
Mean (Standard Deviation)
 35  (6.1)   36  (6.3)   34  (5.0)   35  (5.3)   35  (5.65) 


  Outcome Measures
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1.  Primary:   Incidence of Flushing   [ Time Frame: Hourly for 6 hours on day of dosing ]

2.  Primary:   Time to Flushing   [ Time Frame: 6 hours after dosing ]

3.  Primary:   Duration of Flushing   [ Time Frame: 6 hours after dosing ]

4.  Primary:   Maximum Flushing Severity Score   [ Time Frame: 6 hours after dosing ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Limitations include: pilot design, small sample size, short duration of a one-time niacin dose, utilization of only one niacin formulation.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julie-Ann Dutton, MS, RD
Organization: University of Kansas Medical Center
phone: (913) 588-4064
e-mail: jdutton@kumc.edu



Responsible Party: Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00895193     History of Changes
Other Study ID Numbers: 11627
Study First Received: May 6, 2009
Results First Received: February 3, 2014
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board