HypercholesterolemiaDW-EAZ-OS01NCT07489183
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
An observational study of Hypercholesterolemia, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 641 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2021to 7 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with hypercholesterolemia at moderate risk or higher who are at least 65 years of age and confirmed for treatment
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin/Ezetimibe | Atorvastatin/Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events
Incidence of Adverse events
Measured: 24 weeks to the base
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 Aug 2021
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489183
- Sponsor's protocol ID
- DW-EAZ-OS01
- Acronym
- DW-EAZ-OS01
- Status last verified
- Aug 2021
- First submitted
- 19 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07489183
- Acronym / sponsor ID
- DW-EAZ-OS01 / DW-EAZ-OS01
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin/Ezetimibe | – | –Atorvastatin/Ezetimibe |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with hypercholesterolemia at moderate risk or higher who are at least 65 years of age and confirmed for treatment
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse events
Time frame: 24 weeks to the base
Incidence of Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events (time frame: 24 weeks to the base). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.