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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• 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.

Description

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:

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with hypertension and dislipidemia; received olomax tablet as treatment.	Drug: Olmesartan 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of change in LDL-C	The rate of change in LDL-C at 12 weeks from baseline	at 24 weeks
The amount of change in LDL-C	The amount of change in LDL-C at 24 weeks from baseline	at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of change in LDL-C	The rate of change in LDL-C at 12 weeks from baseline	at 12 weeks
The amount of change in LDL-C	The amount of change in LDL-C at 12 weeks from baseline	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	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	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	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	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	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	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	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	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	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	24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Hun-Sung Kim, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Membrane Transport Modulators; Calcium Channel Blockers; Vasodilator Agents; Antihypertensive Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Olmesartan Medoxomil; Amlodipine; Olmesartan
• Other Study ID Numbers: DWOLM_RWE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Do not have plan yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No