NIPH Clinical Trials Search

JRCT ID: jRCT2031200445

Registered date:25/03/2021

A Dose-finding Trial of ETC-1002(bempedoic acid) in Patients With Hypercholesterolemia

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHypercholesterolemia
Date of first enrollment24/03/2021
Target sample size176
Countries of recruitment
Study typeInterventional
Intervention(s)One ETC-1002(60 mg, 120 mg, or 180 mg) or placebo tablets will be administered orally once daily for 12 weeks.


Primary OutcomePercent change in LDL-C from baseline to Week 12
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 75age old
Include criteria1)Patients who have obtained informed consent to all of the observation/examination/evaluation items specified in the protocol 2)Patients must be on stable statin therapy defined as atorvastatin, pitavastatin, rosuvastatin, pravastatin, simvastatin, or fluvastatin daily[and other lipid-modifying therapies(LMTs) if needed] at least 4 weeks(6 weeks for fibrates) prior to screening and above LDL-C control target. Or Patients for statin intolerant must be on stable LMT(s) at least 4 weeks prior to screening and above LDL-C control target. Statin intolerance defined as an inability to tolerate 1 or more statins due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued or decreased. Patients on the lowest or under the dosage of the approved dose of statin or unable to tolerate any statin at any dose were eligible. Patients could continue taking the lowest or under the dosage of the approved dose of statin therapy or taking other LMTs throughout the study provided that it was stable and well tolerated. 3)Fasting mean TG level < 400 mg/dL from measurements at screening
Exclude criteria1)Women who are pregnant or breastfeeding or who have a positive pregnancy test (urine) result at screening or baseline visits 2)Sexually active male subjects or sexually active female subjects of childbearing potential who do not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after final IMP administration test (urine) result at screening or baseline visits 3)Patients with homozygous familial hypercholesterolemia (HoFH) 4)Patients with a history or current symptoms of any of the following clinically significant cardiovascular diseases within 3 months prior to screening or before baseline visit -Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, or decompensated heart failure -Abdominal aortic aneurysm -Unexplained syncope or long-QT syndrome, family history of long-QT syndrome, or risk factors for Torsade de Pointes, such as persistent hypokalemia or second- or third-degree atrioventricular block (except when controlled by medication, etc) 5)Uncontrolled hypertension, defined as follows: -Sitting systolic blood pressure after resting 5 minutes of>=160 mmHg or diastolic blood pressure of >=100 mmHg at screening 6)Patients with uncontrolled and serious hematologic or coagulation disorders or with Hgb of <10.0 g/dL at screening 7)Patients with type 1 diabetes or uncontrolled type 2 diabetes with hemoglobin A1c (HbA1c) of >=9% at screening 8)Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5x ULN at screening 9)Patients with liver disease or dysfunction, including: -Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies at screening -Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of>=3xULN and/or total bilirubin of>=2xULN 10)Patients with creatine kinase (CK) elevation( >3xULN) at screening 11)Patients with renal dysfunction or nephritic syndrome or a history of nephritis and with estimated glomerular filtration rate (eGFR) of =<30 mL/min/1.73m2 at screening

Related Information


Public contact
Name Center Drug Information
Address 2-16-4, Konan, Minato-ku, Japan Tokyo Japan 108-8242
Telephone +81-3-6361-7314
Affiliation Otsuka Pharmaceutical Co., LTD.
Scientific contact
Name Takehisa Matsumaru
Address 3-2-27, Otedori, Chuo-ku, Osaka, Japan Osaka Japan 540-0021
Telephone +81-6-6943-7722
Affiliation Otsuka Pharmaceutical Co., LTD.