FRESH: FimasaRtan-basEd BP Targets After Drug SwitcHing

• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03649646
• Collaborator: (none)
• Enrollment: 4,542
• Location: 1
• Actual Duration (Months): 27.9
• Patients Per Site Per Month: 162.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 4542 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jul 3, 2018
• Actual Primary Completion Date: Oct 29, 2020
• Actual Study Completion Date: Oct 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients Patients with hypertension uncontrolled by antihypertensive drug

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon		Korea, Republic of

Sponsors and Collaborators

• Boryung Pharmaceutical Co., Ltd

Investigators

• Study Director: Myung Sook Hong, Boryung Pharmaceutical Co., Ltd

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 18, 2018

More Information

Publications

None provided.

• Responsible Party: Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT03649646
• Other Study ID Numbers: BR-FMS-OS-404
• First Posted: Aug 28, 2018
• Last Update Posted: Jan 12, 2021
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Boryung Pharmaceutical Co., Ltd: Hypertension; Fimasartan
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

Participant Flow

Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
Period Title: Overall Study
STARTED	4542
COMPLETED	4075
NOT COMPLETED	467

Baseline Characteristics

Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
Overall Participants	4075
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.63 (12.89)
Sex: Female, Male (Count of Participants)
Female	2184 53.6%
Male	1891 46.4%
Race/Ethnicity, Customized (Count of Participants)
Korean	4075 100%
BMI (kg/㎡) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/㎡]	25.33 (3.36)

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
Measure Participants	4075
Count of Participants [Participants]	3083 75.7%

2. Secondary Outcome

Title	Percentage of Patients With Controlled BP According to 2018 KSH Guideline
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
Measure Participants	4075
Count of Participants [Participants]	2353 57.7%

3. Secondary Outcome

Title	Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
Measure Participants	4075
Count of Participants [Participants]	1454 35.7%

4. Secondary Outcome

Title	Prcentage of Patients With Controlled BP According to Investigator's Target BP
Description	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

Outcome Measure Data

Analysis Population Description

Missing of investigator's target BP: 4 patients

Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
Measure Participants	4071
Count of Participants [Participants]	1388 34.1%

Adverse Events

Time Frame	Week 12
Adverse Event Reporting Description	SAEs and antihypertensive drug related ADRs were collected during the study period.
Arm/Group Title	Patients
Arm/Group Description	Patients with hypertension uncontrolled by antihypertensive drug
All Cause Mortality
	Patients
	Affected / at Risk (%)	# Events
Total	2/4386 (0%)
Serious Adverse Events
	Patients
	Affected / at Risk (%)	# Events
Total	18/4386 (0.4%)
Cardiac disorders
Angina pectoris	1/4386 (0%)	1
Cardiac arrest	1/4386 (0%)	1
Cardiac failure	1/4386 (0%)	1
Coronary artery disease	1/4386 (0%)	1
Eye disorders
Rhegmatogenous retinal detachment	1/4386 (0%)	1
Gastrointestinal disorders
Chronic gastritis	1/4386 (0%)	1
Hepatobiliary disorders
Hepatic cirrhosis	1/4386 (0%)	1
Infections and infestations
Bronchitis	1/4386 (0%)	1
Gastroenteritis	1/4386 (0%)	1
Injury, poisoning and procedural complications
Humerus fracture	1/4386 (0%)	1
Metabolism and nutrition disorders
Hyperkalaemia	2/4386 (0%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone	1/4386 (0%)	1
Nervous system disorders
Cerebral artery occlusion	1/4386 (0%)	1
Cerebral infarction	1/4386 (0%)	1
Dizziness	1/4386 (0%)	1
Transient ischaemic attack	1/4386 (0%)	1
Vascular disorders
Blood pressure inadequately controlled	1/4386 (0%)	1
Other (Not Including Serious) Adverse Events
	Patients
	Affected / at Risk (%)	# Events
Total	37/4386 (0.8%)
Cardiac disorders
Palpitations	2/4386 (0%)	2
Gastrointestinal disorders
Dyspepsia	2/4386 (0%)	2
Epigastric discomfort	2/4386 (0%)	2
Infections and infestations
Bronchitis	2/4386 (0%)	2
Nasopharyngitis	2/4386 (0%)	2
Upper respiratory tract infection	4/4386 (0.1%)	4
Nervous system disorders
Dizziness postural	2/4386 (0%)	2
Dizziness	13/4386 (0.3%)	13
Headache	5/4386 (0.1%)	5
Vascular disorders
Hypotension	3/4386 (0.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.