Alternative Options to Minimize Niacin-Induced Flushing
|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: NCT00895193|
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : March 17, 2014
Last Update Posted : June 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Flushing||Other: Apple pectin Drug: Aspirin 325 mg Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Alternative Options to Minimize Niacin-Induced Flushing|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: Apple-pectin 2000mg
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Other: Apple pectin
Apple pectin 2000mg
Active Comparator: Regular Non-enteric coated aspirin 325mg
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Drug: Aspirin 325 mg
Aspirin 325 mg
Active Comparator: 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.
Other: Apple pectin
Apple pectin 2000mgDrug: Aspirin 325 mg
Aspirin 325 mg
Placebo Comparator: Placebo Comparator
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
- Incidence of Flushing [ Time Frame: Hourly for 6 hours on day of dosing ]Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.
- Time to Flushing [ Time Frame: 6 hours after dosing ]The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.
- Duration of Flushing [ Time Frame: 6 hours after dosing ]The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
- Maximum Flushing Severity Score [ Time Frame: 6 hours after dosing ]Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895193
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Patrick Moriarty, MD||University of Kansas Medical Center|