Trial Outcomes & Findings for FimasaRtan-basEd BP Targets After Drug SwitcHing (NCT NCT03649646)

NCT ID: NCT03649646

Last Updated: 2021-01-12

Results Overview

Percentage of patients who attain the target blood pressure (BP) (\<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change

• Recruitment status: COMPLETED
• Target enrollment: 4542 participants
• Primary outcome timeframe: Week 12 after the treatment regimen change
• Results posted on: 2021-01-12

Participant Flow

Participant milestones

Measure	Patients Patients with hypertension uncontrolled by antihypertensive drug
Overall Study STARTED	4542
Overall Study COMPLETED	4075
Overall Study NOT COMPLETED	467

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FimasaRtan-basEd BP Targets After Drug SwitcHing

Baseline characteristics by cohort

Measure	Patients n=4075 Participants Patients with hypertension uncontrolled by antihypertensive drug
Age, Continuous	61.63 years STANDARD_DEVIATION 12.89 • n=5 Participants
Sex: Female, Male Female	2184 Participants n=5 Participants
Sex: Female, Male Male	1891 Participants n=5 Participants
Race/Ethnicity, Customized Korean	4075 Participants n=5 Participants
BMI	25.33 kg/㎡ STANDARD_DEVIATION 3.36 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Patients n=4075 Participants Patients with hypertension uncontrolled by antihypertensive drug
Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)	3083 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Patients n=4075 Participants Patients with hypertension uncontrolled by antihypertensive drug
Percentage of Patients With Controlled BP According to 2018 KSH Guideline	2353 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Patients n=4075 Participants Patients with hypertension uncontrolled by antihypertensive drug
Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline	1454 Participants

SECONDARY outcome

Timeframe: Week 12 after the treatment regimen change

Population: Missing of investigator's target BP: 4 patients

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.

Outcome measures

Measure	Patients n=4071 Participants Patients with hypertension uncontrolled by antihypertensive drug
Prcentage of Patients With Controlled BP According to Investigator's Target BP	1388 Participants

Adverse Events

Patients

Serious events: 18 serious events

Other events: 37 other events

Deaths: 2 deaths

Serious adverse events

Measure	Patients n=4386 participants at risk Patients with hypertension uncontrolled by antihypertensive drug
Cardiac disorders Angina pectoris	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Cardiac disorders Cardiac arrest	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Cardiac disorders Cardiac failure	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Cardiac disorders Coronary artery disease	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Eye disorders Rhegmatogenous retinal detachment	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Gastrointestinal disorders Chronic gastritis	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Hepatobiliary disorders Hepatic cirrhosis	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Infections and infestations Bronchitis	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Infections and infestations Gastroenteritis	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Injury, poisoning and procedural complications Humerus fracture	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Metabolism and nutrition disorders Hyperkalaemia	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Cerebral artery occlusion	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Cerebral infarction	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Dizziness	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Transient ischaemic attack	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Vascular disorders Blood pressure inadequately controlled	0.02% 1/4386 • Number of events 1 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.

Other adverse events

Measure	Patients n=4386 participants at risk Patients with hypertension uncontrolled by antihypertensive drug
Cardiac disorders Palpitations	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Gastrointestinal disorders Dyspepsia	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Gastrointestinal disorders Epigastric discomfort	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Infections and infestations Bronchitis	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Infections and infestations Nasopharyngitis	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Infections and infestations Upper respiratory tract infection	0.09% 4/4386 • Number of events 4 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Dizziness postural	0.05% 2/4386 • Number of events 2 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Dizziness	0.30% 13/4386 • Number of events 13 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Nervous system disorders Headache	0.11% 5/4386 • Number of events 5 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.
Vascular disorders Hypotension	0.07% 3/4386 • Number of events 3 • Week 12 SAEs and antihypertensive drug related ADRs were collected during the study period.

Additional Information

Myung Sook Hong

Boryung Pharm. CO., LTD

Phone: 82-2-708-8238

Email: mshong@boryung.co.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place