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A multicenter, open-label, uncontrolled, long-term trial to assess the safety and efficacy of ETC-1002 in patients with hyper-LDL cholesterolemia

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

Matsumaru Takehisa

Otsuka Pharmaceutical Co., LTD.

3-2-27, Otedori, Chuo-ku, Osaka, Japan

OPC_346-102-00002@otsuka.jp

Drug Information Center

Otsuka Pharmaceutical Co., LTD.

2-16-4, Konan, Minato-ku, Tokyo, Japan

+81-3-6361-7314

opc_ctr@otsuka.jp

Not Recruiting

Feb. 27, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1)Patients with inadequate response to statins or who have difficulty in treatment with statins as defined below
[Inadequate response to statins]
Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C
[Difficulty in treatment with statins]
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, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins 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

1)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
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

Both

Hyper-low-density lipoprotein (LDL) cholesterolemia

One ETC-1002(180 mg) tablet will be administered orally once daily for 52 weeks.

Adverse events (AEs), clinical laboratory tests, vital signs (blood pressure, pulse rate, and body temperature), body weight, physical examination, and 12-lead electrocardiogram (ECG)

+81-42-648-5551

Dec. 08, 2022

Yes

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data. Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

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