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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
277
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
325 mg tablets administered once daily
Tablets administered once daily
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
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.
Time frame: From Baseline to end of Week 1
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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Scottsdale, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Newport Beach, California, United States
Unnamed facility
Stockton, California, United States
Unnamed facility
Vista, California, United States
Unnamed facility
Westlake Village, California, United States
...and 16 more locations