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A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia

NCT04784442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-05-10

Study results available
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Summary

The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks.

Conditions

Interventions

DRUG

180mg of ETC-1002(bempedoic acid)

180mg, tablet, once daily, for 12 weeks

DRUG

120mg of ETC-1002(bempedoic acid)

120mg, tablet, once daily, for 12 weeks

DRUG

60mg of ETC-1002(bempedoic acid)

60mg, tablet, once daily, for 12 weeks

DRUG

Placebo

placebo, tablet, once daily, for 12 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takehisa Matsumaru · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2022-04-18
Completion
2022-05-17

Countries

  • Japan

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784442 on ClinicalTrials.gov