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Active, not recruitingNCT05660135Updated Aug 24, 2025

Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia

An observational study in Hypertension and Dyslipidemias, sponsored by Daewoong Pharmaceutical Co. LTD.. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
4,000
Ages
19 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Hypertension
  • Dyslipidemias
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Adult aged 19 or older at the time of the baseline visit.
  2. 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
  3. A person who can understand the information provided to him/her and may voluntarily sign a written consent form

Exclusion criteria

Exclusion Criteria:

  1. A person who falls under the prohibition of administration according to the permission for olomax tablet
  2. A person who has a history of administering olomax tablets before participating in this study
  3. In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with hypertension and dislipidemia

    received olomax tablet as treatment.

    Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca

Interventions

  • DrugOlmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca

    Olomax Tab 20/5/5mg Olomax Tab 20/5/10mg Olomax Tab 40/5/5mg Olomax Tab 40/5/10mg

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What researchers measure

Primary outcomes

  1. The rate of change in LDL-C

    The rate of change in LDL-C at 12 weeks from baseline

    Time frame: at 24 weeks

  2. The amount of change in LDL-C

    The amount of change in LDL-C at 24 weeks from baseline

    Time frame: at 24 weeks

Secondary outcomes

  1. The rate of change in LDL-C

    The rate of change in LDL-C at 12 weeks from baseline

    Time frame: at 12 weeks

  2. The amount of change in LDL-C

    The amount of change in LDL-C at 12 weeks from baseline

    Time frame: at 12 weeks

  3. The rate of change in SBP(Systolic Blood Pressure)

    The rate of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline

    Time frame: 12 weeks

  4. The rate of change in SBP(Systolic Blood Pressure)

    The rate of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline

    Time frame: 24 weeks

  5. The amount of change in SBP(Systolic Blood Pressure)

    The amount of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline

    Time frame: 12 weeks

  6. The amount of change in SBP(Systolic Blood Pressure)

    The amount of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline

    Time frame: 24 weeks

  7. 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

    Time frame: 12 weeks

  8. 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

    Time frame: 24 weeks

  9. 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

    Time frame: 12 weeks

  10. 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

    Time frame: 24 weeks

  11. 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

    Time frame: 12 weeks

  12. 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

    Time frame: 24 weeks

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Study locations

1 site
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
    Seoul, South Korea
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References and documents

Individual participant data

Plan to share: Undecided — Do not have plan yet

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05660135
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Dec 21, 2022
Start date
Jun 20, 2022
Primary completion
Nov 30, 2024
Completion
Dec 31, 2025 (estimated)
Last update
Aug 24, 2025

Study contacts

Hun-Sung Kim
principal investigator · The Catholic University of Korea

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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