NCT07489183

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
641

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse events

    Incidence of Adverse events

    24 weeks to the base

Study Arms (1)

Atorvastatin/Ezetimibe

Atorvastatin/Ezetimibe

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Building 1897

Seoul, 04516, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 24, 2026

Study Start

August 23, 2021

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

March 24, 2026

Record last verified: 2021-08

Locations

KR(1)