Clinical trial NCT03649646: FimasaRtan-basEd BP Targets After Drug SwitcHing
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: Hypertension
Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 4542
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)
timeFrame: Week 12 after the treatment regimen change
Secondary outcomes:
measure: Percentage of Patients With Controlled BP According to 2018 KSH Guideline
timeFrame: Week 12 after the treatment regimen change
measure: Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline
timeFrame: Week 12 after the treatment regimen change
measure: Prcentage of Patients With Controlled BP According to Investigator's Target BP
timeFrame: Week 12 after the treatment regimen change
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Myung Sook Hong
role: STUDY_DIRECTOR
References: