Essential Hypertension
Conditions
Keywords
Hypertension, Fimasartan
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.
Interventions
None listed
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg) | Week 12 after the treatment regimen change | Percentage of patients who attain the target blood pressure (BP) (\<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Controlled BP According to 2018 KSH Guideline | Week 12 after the treatment regimen change | 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 |
| Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline | Week 12 after the treatment regimen change | 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 |
| Prcentage of Patients With Controlled BP According to Investigator's Target BP | Week 12 after the treatment regimen change | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Patients with hypertension uncontrolled by antihypertensive drug | 4,075 |
| Total | 4,075 |
Baseline characteristics
| Characteristic | Patients |
|---|---|
| Age, Continuous | 61.63 years STANDARD_DEVIATION 12.89 |
| BMI | 25.33 kg/㎡ STANDARD_DEVIATION 3.36 |
| Race/Ethnicity, Customized Korean | 4075 Participants |
| Sex: Female, Male Female | 2184 Participants |
| Sex: Female, Male Male | 1891 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 4,386 |
| other Total, other adverse events | 37 / 4,386 |
| serious Total, serious adverse events | 18 / 4,386 |
Outcome results
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
Time frame: Week 12 after the treatment regimen change
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg) | 3083 Participants |
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
Time frame: Week 12 after the treatment regimen change
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline | 1454 Participants |
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
Time frame: Week 12 after the treatment regimen change
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Percentage of Patients With Controlled BP According to 2018 KSH Guideline | 2353 Participants |
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.
Time frame: Week 12 after the treatment regimen change
Population: Missing of investigator's target BP: 4 patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Prcentage of Patients With Controlled BP According to Investigator's Target BP | 1388 Participants |