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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660135
• Other study ID #: DWOLM_RWE02
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: ?? ?
• Phone: +821029945887
• Email: 2210325[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca
Olomax Tab 20/5/5mg Olomax Tab 20/5/10mg Olomax Tab 40/5/10 mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of change	in Low-density Lipoprotein cholesterol	at 24 weeks
Primary	The amount of change	in Low-density Lipoprotein cholesterol	at 24 weeks
Secondary	The rate of change	in Low-density Lipoprotein cholesterol	at 12 weeks
Secondary	The amount of change	in Low-density Lipoprotein cholesterol	at 12 weeks