FimasaRtan-basEd BP Targets After Drug SwitcHing

Essential Hypertension Clinical Trial

— FRESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649646
• Other study ID #: BR-FMS-OS-404
• Status: Completed
• Start date: July 3, 2018
• Est. completion date: October 29, 2020

Study information

• Verified date: August 2018
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4542
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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