FimasaRtan-basEd BP Targets After Drug SwitcHing

NCT ID: NCT03649646

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4542 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2020-10-29

Brief Summary

The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.

Detailed Description

This study will be performed in patients with blood pressure (BP) uncontrolled by existing antihypertensive drugs (including ARB) among hypertensive patients visiting outpatient clinic of medical institutions in Korea. The study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. Follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.

Conditions

Essential Hypertension

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients with hypertension uncontrolled by antihypertensive drug

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study
• Male or female adults ≥ 19 years who are diagnosed with essential hypertension
• Receiving outpatient treatment at the time of study enrollment
• Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens decided and scheduled to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)

• Definition of uncontrolled hypertension: Target BP (SBP <140 mmHg and DBP <90 mmHg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer

Exclusion Criteria

• Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
• Patients with suspected or confirmed secondary hypertension
• Pregnant or breast-feeding women
• Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
• Patients who are determined inappropriate for participating in the study by investigators for other reasons

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung Sook Hong

Role: STUDY_DIRECTOR

Boryung Pharmaceutical Co., Ltd

Locations

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BR-FMS-OS-404

Identifier Type: -

Identifier Source: org_study_id