A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant
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.
Inclusion Criteria:
Age between 18 and 85 years
History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:
Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.
Exclusion Criteria:
Ciudad Autónoma de Buenos Aires, Buenos Aires 1426, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1179AAB, Argentina
Caba, Ciudad Autonoma C1419GEP, Argentina
Ciudad Autónoma de Buenos Aire, Ciudad Autonoma C1093AAS, Argentina
Ciudad Autónoma de Buenos Aire, Ciudad Autonoma C1119ACN, Argentina
Ciudad Autónoma de Buenos Aire, Ciudad Autonoma C1425DES, Argentina
Ciudad Autónoma de Buenos Aire, Ciudad Autonoma C1428ART, Argentina
Ciudad Autónoma de Buenos Aire, Ciudad Autonoma C1430CKE, Argentina
Ciudad Autonoma Buenos Aires, C1118AAE, Argentina
Ciudad Autonoma Buenos Aires, C1128AAE, Argentina
Praha 4 - Krc, 140 59, Czechia
Århus N, 8200, Denmark
Copenhagen NV, 2400, Denmark
Dresden, Baden-Wurttemberg 01307, Germany
Mainz, Hesse 55128, Germany
Altenburg, Saxony 04600, Germany
Hyderabad, Andhra Pradesh 500034, India