HypertensionNCT05660135
Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
An observational study of Hypertension and Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemias
- What is being tested?
- Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca
- Type of treatment
- Pill or oral medicine
- How many people
- 4,000 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: This study is to confirm the effect of olomax tablet -reducing blood pressure and LDL-C- in patients with hypertension and dyslipidemia compared to existing drugs . Of the total 4,672,648 statin prescriptions in 2020, about 295,379 were combined prescriptions for hypertension treatment. It was expected that about 1% of them could be registered, and therefore we estimated 4,000 study subjects to be recruited.
Who may be able to join
- Adult aged 19 or older at the time of the baseline visit.
- A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement.
- Patients who were previously taking more than two tablets of a single drug, low-density lipoprotein-cholesterol (LDL-C)
- Patients who were previously only taking blood pressure-lowering drugs and did not take LDL-C-lowering drugs, but who need to take additional LDL-C-lowering drugs at the discretion of the researcher
- Patients who were previously taking LDL-C lowering agents and did not take blood pressure lowering agents, but who need to take additional blood pressure lowering agents according to the researcher's judgment
- Patients who have not previously taken both a blood pressure drop and an LDL-C drop but need additional simultaneous use at the discretion of the researcher
- A person who can understand the information provided to him/her and may voluntarily sign a written consent form
Who cannot join
- A person who falls under the prohibition of administration according to the permission for olomax tablet
- A person who has a history of administering olomax tablets before participating in this study
- In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
About this study
Official title: Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study
This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.
Read the detailed description
In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin CaDrug
Olomax Tab 20/5/5mg Olomax Tab 20/5/10mg Olomax Tab 40/5/5mg Olomax Tab 40/5/10mg
| Study group | Role | What they receive |
|---|---|---|
| patients with hypertension and dislipidemia | received olomax tablet as treatment. Receives: Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of change in LDL-C
The rate of change in LDL-C at 12 weeks from baseline
Measured: at 24 weeks
The amount of change in LDL-C
The amount of change in LDL-C at 24 weeks from baseline
Measured: at 24 weeks
Secondary outcomes (12)
The rate of change in LDL-C
The rate of change in LDL-C at 12 weeks from baseline
Measured: at 12 weeks
The amount of change in LDL-C
The amount of change in LDL-C at 12 weeks from baseline
Measured: at 12 weeks
The rate of change in SBP(Systolic Blood Pressure)
The rate of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline
Measured: 12 weeks
The rate of change in SBP(Systolic Blood Pressure)
The rate of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline
Measured: 24 weeks
The amount of change in SBP(Systolic Blood Pressure)
The amount of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline
Measured: 12 weeks
The amount of change in SBP(Systolic Blood Pressure)
The amount of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline
Measured: 24 weeks
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 12 weeks from baseline
Measured: 12 weeks
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline
Measured: 24 weeks
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 12 weeks from baseline
Measured: 12 weeks
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline
Measured: 24 weeks
Percentage of subjects who reached LDL-C target
Percentage of subjects who reached LDL-C target according to Korean Society of Lipid/Arteriosclerosis's risk classification in the guidelines for the treatment of dyslipidemia (2018) at 12 weeks from baseline
Measured: 12 weeks
Percentage of subjects who reached LDL-C target
Percentage of subjects who reached LDL-C target according to Korean Society of Lipid/Arteriosclerosis's risk classification in the guidelines for the treatment of dyslipidemia (2018) at 24 weeks from baseline
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 posted21 Dec 2022
- Study start20 Jun 2022
- Primary completion30 Nov 2024
- 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 HypertensionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hun-Sung Kim, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660135
- Sponsor's protocol ID
- DWOLM_RWE02
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Do not have plan yet
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
- Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study
- ClinicalTrials.gov ID
- NCT05660135
- Acronym / sponsor ID
- DWOLM_RWE02
- Conditions
- Hypertension, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Dec 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.
This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.
Detailed description
In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hypertension and dislipidemia | – | Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Careceived olomax tablet as treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is to confirm the effect of olomax tablet -reducing blood pressure and LDL-C- in patients with hypertension and dyslipidemia compared to existing drugs . Of the total 4,672,648 statin prescriptions in 2020, about 295,379 were combined prescriptions for hypertension treatment. It was expected that about 1% of them could be registered, and therefore we estimated 4,000 study subjects to be recruited.
Key inclusion criteria (7 listed)
- Adult aged 19 or older at the time of the baseline visit.
- A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement.
- A person who can understand the information provided to him/her and may voluntarily sign a written consent form
Key exclusion criteria (3 listed)
- A person who falls under the prohibition of administration according to the permission for olomax tablet
- A person who has a history of administering olomax tablets before participating in this study
- In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;
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 |
|---|---|---|
| Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin CaOlomax Tab 20/5/5mg Olomax Tab 20/5/10mg Olomax Tab 40/5/5mg Olomax Tab 40/5/10mg | Drug | patients with hypertension and dislipidemia |
Primary outcome
The rate of change in LDL-C
Time frame: at 24 weeks
The rate of change in LDL-C at 12 weeks from baseline
The amount of change in LDL-C
Time frame: at 24 weeks
The amount of change in LDL-C at 24 weeks from baseline
12 secondary outcomes
The rate of change in LDL-C
Time frame: at 12 weeks
The amount of change in LDL-C
Time frame: at 12 weeks
The rate of change in SBP(Systolic Blood Pressure)
Time frame: 12 weeks
The rate of change in SBP(Systolic Blood Pressure)
Time frame: 24 weeks
The amount of change in SBP(Systolic Blood Pressure)
Time frame: 12 weeks
The amount of change in SBP(Systolic Blood Pressure)
Time frame: 24 weeks
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
Time frame: 12 weeks
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
Time frame: 24 weeks
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
Time frame: 12 weeks
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
Time frame: 24 weeks
Percentage of subjects who reached LDL-C target
Time frame: 12 weeks
Percentage of subjects who reached LDL-C target
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: Undecided. Do not have plan yet
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Hun-Sung Kim principal investigator
The Catholic University of Korea
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 Hypertension and Dyslipidemias, 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 7 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?
The rate of change in LDL-C (time frame: at 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.