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 (ASA EFFECTS)

NCT00626392 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	277
Start date	2008-02
Completion	2008-04

Conditions

• Dyslipidemia

Interventions

• niacin extended-release (NER)
• aspirin (ASA)
• aspirin placebo (ASA Pbo)

Primary outcomes

• Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment — 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.

Countries

United States