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

NCT05660135 | Active Not Recruiting

• 1 other identifier: DWOLM_RWE02
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• The rate of change in LDL-C

  at 12 weeks

• The amount of change in LDL-C

  at 12 weeks

• The rate of change in SBP(Systolic Blood Pressure)

  12 weeks

• The rate of change in SBP(Systolic Blood Pressure)

  24 weeks

• The amount of change in SBP(Systolic Blood Pressure)

  12 weeks

Study Arms (1)

patients with hypertension and dislipidemia

received olomax tablet as treatment.

Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca

Interventions

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

patients with hypertension and dislipidemia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

Olmesartan Medoxomil; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines

Study Officials

• Hun-Sung Kim

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: June 20, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

KR (1)