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Active, Not Recruiting

NCT Number: NCT05660135

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;

Treatment and study plan

Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca

Drug

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

Primary outcomes

  1. The rate of change in LDL-C

    Time frame: at 24 weeks

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

  2. The amount of change in LDL-C

    Time frame: at 24 weeks

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

Secondary outcomes

  1. The rate of change in LDL-C

    Time frame: at 12 weeks

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

  2. The amount of change in LDL-C

    Time frame: at 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 24 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 24 weeks

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

  7. 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) at 12 weeks from baseline

  8. The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)

    Time frame: 24 weeks

    The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline

  9. 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) at 12 weeks from baseline

  10. The amount 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) at 24 weeks from baseline

  11. Percentage of subjects who reached LDL-C target

    Time frame: 12 weeks

    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

  12. Percentage of subjects who reached LDL-C target

    Time frame: 24 weeks

    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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 21, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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