Clinical Trials Directory

Trials / Completed

CompletedNCT04784442

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
188 (actual)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
20 Years – 74 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUG180mg of ETC-1002(bempedoic acid)180mg, tablet, once daily, for 12 weeks
DRUG120mg of ETC-1002(bempedoic acid)120mg, tablet, once daily, for 12 weeks
DRUG60mg of ETC-1002(bempedoic acid)60mg, tablet, once daily, for 12 weeks
DRUGPlaceboplacebo, tablet, once daily, for 12 weeks

Timeline

Start date
2021-03-24
Primary completion
2022-04-18
Completion
2022-05-17
First posted
2021-03-05
Last updated
2024-05-10
Results posted
2024-03-04

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT04784442. Inclusion in this directory is not an endorsement.