FimasaRtan-basEd BP Targets After Drug SwitcHing (FRESH)

A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target BP Attainment in Patients Whose Antihypertensive Regimens Are Changed to ARB-based Therapy

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension

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.

• Study Type: Observational
• Enrollment (Actual): 4542

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertension uncontrolled by antihypertensive drugs* whose antihypertensive regimens are changed to angiotensin receptor blocker (ARB) monotherapy or concomitant antihypertensive drug therapy containing ARB.

*Including patients who previously received angiotensin receptor blocker (ARB); in this case, changing to other therapy using an ARB with different ingredient is allowed.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; Patients with hypertension uncontrolled by antihypertensive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)	Percentage of patients who attain the target blood pressure (BP) (<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change	Week 12 after the treatment regimen change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Controlled BP According to 2018 KSH Guideline	Percentage of patients who attain the target BP specified in 2018 hypertension clinical practice guidelines* suggested by Korean Society of Hypertension at Week 12 after the treatment regimen change. *2018 hypertension clinical practice guidelines : Target BP <140(SBP)/90(DBP) mmHg. For patients meeting any of the conditions listed below, each corresponding criterion will be applied.; Patients with cardiovascular disease :<130/80 mmHg; Patients with diabetes : <140/85 mmHg; Patients with diabetes accompanying cardiovascular disease :<130/80 mmHg; Patients with chronic kidney disease accompanying albuminuria: <130/80 mmHg	Week 12 after the treatment regimen change
Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline	Percentage of patients who attain the target BP(<130(SBP)/80(DBP)mmHg) specified in 2017 clinical practice guidelines for hypertension suggested by American College of Cardiology(ACC)/American Heart Association(AHA) at Week 12 after the treatment regimen change	Week 12 after the treatment regimen change
Prcentage of Patients With Controlled BP According to Investigator's Target BP	Percentage of patients who attain the investigator's target BP* at Week 12 after the treatment regimen change. *Investigator's target BP: Target BP for each patient set by the investigator at baseline.	Week 12 after the treatment regimen change

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2018
• Primary Completion (ACTUAL): October 29, 2020
• Study Completion (ACTUAL): October 29, 2020

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Fimasartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: BR-FMS-OS-404

Drug and device information, study documents

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