HyperlipidemiasNCT05411887
Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab
An observational study of Hyperlipidemias and Hypertension, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperlipidemias, Hypertension
- What is being tested?
- Rosuvastatin, Olmesartan Medoxomil
- Type of treatment
- Pill or oral medicine
- How many people
- 2,845 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3000 subjects is a sufficient number to produce a meaningful model considering discriminant analysis and regression analysis that will be conducted in the secondary evaluation
Who may be able to join
- men and women over the age of 19
- Patients who signed a written consent form to participate in the study
- Patients who are eligible for Olostar tablet prescription according to domestic permission
Who cannot join
- A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual
- Patients in hospital (hospitals only; nursing care facilities can be recruited)
- A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.
The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.
- Conditions
- Hyperlipidemias, Hypertension
- Being tested
- Rosuvastatin, Olmesartan Medoxomil
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin, Olmesartan MedoxomilDrug
Olostar Tablet
| Study group | Role | What they receive |
|---|---|---|
| Experimental/ Olostar Tablet | Eligible Subjects who received Olostar Tablet treatment for 24 weeks. Dosage: 10/5mg, 10/10mg, 20/5mg, 20/10mg, 20/20mg, 40/10mg, 40/20mg Receives: Drug: Rosuvastatin, Olmesartan Medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline
Measured: 24 weeks
absolute change and rate of change in systolic and diastolic blood pressure
Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline
Measured: 24 weeks
Secondary outcomes (13)
Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals
Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals assessed 6 months after administration of Olosta tablets
Measured: 24 weeks
LDL-C treatment goal achievement rate
LDL-C treatment goal achievement rate at 24 weeks
Measured: 24 weeks
Blood pressure treatment goal achievement rate
Blood pressure treatment goal achievement rate at 24 weeks
Measured: 24 weeks
Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg
Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg at 24 weeks
Measured: 24 weeks
Olostar tablet compliance
Olostar tablet compliance at 24 weeks
Measured: 24 weeks
Olostar tablet dose change
Olostar tablet dose change: ① Proportion of subjects by initial dose, ② Average number of dose changes, ③ Proportion of subjects by dose at the end at 24 weeks
Measured: 24 weeks
Olostar Tablet persistence
Olostar Tablet persistence: ① persistence rate; ② Median time to discontinuation; ③ Evaluation of reasons for suspension
Measured: 24 weeks
Evaluation of compliance
Evaluation of compliance with therapeutic lifestyle improvement (eating habits and amount of exercise)
Measured: 24 weeks
Assessment of Variables Influencing the Simultaneous Achievement of General
Assessment of Variables Influencing the Simultaneous Achievement of General Treatment Goals for Hypertension and Low-Density Lipoprotein Cholesterol (LDL-C) Treatment Goals and the Creation of a Predictive Model at 24 weeks
Measured: 24 weeks
Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.)
Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) at 24 weeks
Measured: 24 weeks
Evaluation of variables affecting compliance and persistence with Olostar tablets
Evaluation of variables affecting compliance and persistence with Olostar tablets at 24 weeks
Measured: 24 weeks
Evaluation of convenience of taking Olostar tablets
Evaluation of convenience of taking Olostar tablets at 24 weeks
Measured: 24 weeks
Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets
Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets at 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start20 Jun 2022
- Primary completion31 Mar 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeWon Oh, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411887
- Sponsor's protocol ID
- DWOS_OLO_004
- Status last verified
- Aug 2025
- First submitted
- 19 May 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.
- ClinicalTrials.gov ID
- NCT05411887
- Acronym / sponsor ID
- DWOS_OLO_004
- Conditions
- Hyperlipidemias, Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,845 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jun 2022 (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.
The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental/ Olostar Tablet | – | Drug: Rosuvastatin, Olmesartan MedoxomilEligible Subjects who received Olostar Tablet treatment for 24 weeks. Dosage: 10/5mg, 10/10mg, 20/5mg, 20/10mg, 20/20mg, 40/10mg, 40/20mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3000 subjects is a sufficient number to produce a meaningful model considering discriminant analysis and regression analysis that will be conducted in the secondary evaluation
Key inclusion criteria (3 listed)
- men and women over the age of 19
- Patients who signed a written consent form to participate in the study
- Patients who are eligible for Olostar tablet prescription according to domestic permission
Key exclusion criteria (3 listed)
- A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual
- Patients in hospital (hospitals only; nursing care facilities can be recruited)
- A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin, Olmesartan MedoxomilOlostar Tablet | Drug | Experimental/ Olostar Tablet |
Primary outcome
absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
Time frame: 24 weeks
Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline
absolute change and rate of change in systolic and diastolic blood pressure
Time frame: 24 weeks
Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline
13 secondary outcomes
Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals
Time frame: 24 weeks
LDL-C treatment goal achievement rate
Time frame: 24 weeks
Blood pressure treatment goal achievement rate
Time frame: 24 weeks
Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg
Time frame: 24 weeks
Olostar tablet compliance
Time frame: 24 weeks
Olostar tablet dose change
Time frame: 24 weeks
Olostar Tablet persistence
Time frame: 24 weeks
Evaluation of compliance
Time frame: 24 weeks
Assessment of Variables Influencing the Simultaneous Achievement of General
Time frame: 24 weeks
Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.)
Time frame: 24 weeks
Evaluation of variables affecting compliance and persistence with Olostar tablets
Time frame: 24 weeks
Evaluation of convenience of taking Olostar tablets
Time frame: 24 weeks
Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
JaeWon Oh principal investigator
Severance Hospital
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 Hyperlipidemias and Hypertension, run by Daewoong 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 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 Aug 2025.