drugset / Trial / NCT02993406

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

Phase 3 Completed 13970 enrolled Esperion Therapeutics, Inc. The Cleveland Clinic · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.

Timeline

Start: 2016-12-22
Primary completion: 2022-11-07
Completion: 2022-11-07

Outcome

Met primary endpoint

registry analysis (superiority test); Bempedoic Acid 180 mg vs Placebo Comparator; p = 0.004; Hazard Ratio (HR) 0.87 (95% CI 0.79 to 0.96); Log Rank reads as unknown NCT02993406 ↗

release “CLEAR Outcomes trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo.” reads as met primary endpoint esperion.com ↗

release “CLEAR Outcomes met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo.” reads as met primary endpoint esperion.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bempedoic acid	Small molecule	180 mg	Oral