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

Active, not recruiting

• Conditions: Dyslipidemias; Hypertension
• Interventions: Drug: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca

• Registration Number: NCT05660135
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

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 Timeline

• Study Start: 2022-06-20
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Primary Completion: 2024-11-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with hypertension and dislipidemia	Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca	received olomax tablet as treatment.

Primary Outcome Measures

Name	Time	Method
The rate of change in LDL-C	at 24 weeks	The rate of change in LDL-C at 12 weeks from baseline
The amount of change in LDL-C	at 24 weeks	The amount of change in LDL-C at 24 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
The rate of change in LDL-C	at 12 weeks	The rate of change in LDL-C at 12 weeks from baseline
The amount of change in LDL-C	at 12 weeks	The amount of change in LDL-C at 12 weeks from baseline
The amount of change in SBP(Systolic Blood Pressure)	24 weeks	The amount of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline
The rate of change in SBP(Systolic Blood Pressure)	24 weeks	The rate of change in SBP(Systolic Blood Pressure) at 24 weeks from baseline
The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)	24 weeks	The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline
The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)	24 weeks	The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 24 weeks from baseline
Percentage of subjects who reached LDL-C target	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

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of