NIPH Clinical Trials Search

JRCT ID: jRCT2031220562

Registered date:11/01/2023

A confirmatory trial of ETC-1002 in patients with hyper-LDL cholesterolemia

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHyper-low-density lipoprotein (LDL) cholesterolemia
Date of first enrollment13/02/2023
Target sample size96
Countries of recruitment
Study typeInterventional
Intervention(s)One ETC-1002(180 mg) or placebo tablets will be administered orally once daily for 12 weeks.


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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 85age old
Include criteria1)Patients with inadequate response to statins or statin intolerance as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who have been taking statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Statin intolerance] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s). 2)Patients with fasting TG levels of <400 mg/dL at screening
Exclude criteria1)Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits 2)Patients with homozygous familial hypercholesterolemia (HoFH) 3)Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening or before baseline visit 4)Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of >=160 mmHg or diastolic blood pressure of >=100 mmHg at screening 5)Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening 6)Patients with uncontrolled diabetes with HbA1c of >=9% at screening 7)Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 x ULN at screening 8)Patients with liver disease or dysfunction, including: -Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening -Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of >=3 x ULN or total bilirubin of >=2 x ULN at screening 9)Patients with creatine kinase (CK) of >3 x ULN at screening 10)Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of <=30 mL/min/1.73 m2 at screening

Related Information


Public contact
Name Drug Information Center
Address 2-16-4, Konan, Minato-ku, Tokyo, 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.