A Prospective, Open, Observational Study to Confirm the Lipid-lowering Effect, Changes in Glucose Metabolism, and Safety After 6 Months of Administration of Atostazet to Hypercholesterolemic Patients 65 Years of Age or Older (DW-EAZ-OS01)

March 19, 2026 updated by: Dong Wha Pharmaceutical Co. Ltd.
A prospective, open, observational study to confirm the lipid-lowering effect, changes in glucose metabolism, and safety after 6 months of administration of atostazet to hypercholesterolemic patients 65 years of age or older

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

641

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hypercholesterolemia at moderate risk or higher who are at least 65 years of age and confirmed for treatment

Description

Inclusion Criteria:

  • Males or females aged ≥ 65 years
  • Primary Hypercholesterolemia
  • moderate risk or higher patient based on Korean Guidelines for the Management of Dyslipidemia (the 4th edition)

Exclusion Criteria:

  • Patients with a known hypersensitivity to any of the major or minor components of the study drug
  • Patients with active hepatic disease or unexplained persistently elevated serum aminotransferase levels
  • Patients with myopathies
  • Patients receiving glecaprevir and pibrentasvir

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Atorvastatin/Ezetimibe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse events
Time Frame: 24 weeks to the base
Incidence of Adverse events
24 weeks to the base

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong Wha Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Actual)

September 7, 2023

Study Completion (Actual)

September 7, 2023

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW-EAZ-OS01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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