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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07489183
Acronym
DW-EAZ-OS01
Enrollment
641
Registered
2026-03-24
Start date
2021-08-23
Completion date
2023-09-07
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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

Interventions

None listed

Sponsors

Dong Wha Pharmaceutical Co. Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Adverse events24 weeks to the baseIncidence of Adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026