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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with hypertension uncontrolled by antihypertensive drug |
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| 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 |
| 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.
|
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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)
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Myung Sook Hong | Boryung Pharmaceutical Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients | Patients with hypertension uncontrolled by antihypertensive drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients | Patients with hypertension uncontrolled by antihypertensive drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Week 12 after the treatment regimen change |
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|
Week 12
SAEs and antihypertensive drug related ADRs were collected during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients | Patients with hypertension uncontrolled by antihypertensive drug | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myung Sook Hong | Boryung Pharm. CO., LTD | 82-2-708-8238 | mshong@boryung.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | Nov 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/㎡ |
|
|
| 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.
| Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Missing of investigator's target BP: 4 patients | Posted | Count of Participants | Participants | Week 12 after the treatment regimen change |
|
|
|
| 4,386 |
| 18 |
| 4,386 |
| 37 |
| 4,386 |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Cerebral artery occlusion | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Blood pressure inadequately controlled | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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