Fimasartan Optimal Reduction Targeting Elevated Blood Pre... | NCT03254914

Studies
Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study

NCT03254914

Sponsor

Boryung Pharmaceutical Co., Ltd

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

3,554Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Home Blood Pressure

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2017Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Aug 17, 2017

First Submission Date that Met QC Criteria

Aug 17, 2017

First Posted Date

Aug 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan

Detailed Description

A multi-center, cluster-randomized, prospective, observational study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,554Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Site		Measure Clinic Blood Pressure
Test Site		Measure Clinic Blood Pressure and Home Blood Pressure	Procedure: Home Blood Pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home Blood Pressure	Procedure	Measure Home Blood Pressure	Test Site

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of reaching target blood pressure	Rate of reaching target blood pressure after treatment for 12 weeks	12 weeks after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who voluntarily signed informed consent for participating in this clinical study
Male and female over the age of 19
Hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan

Exclusion Criteria:

Renal dialysis patients.
Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor.
Severe renal disorder
Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Medical history with hypersensitivity to Fimasartan
Pregnant women or lactating female.
Participate in another clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hypertensive patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national university hospital		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33317628	Derived	Choi JY, Kim KI, Kim CH. Effect of home blood pressure monitoring for blood pressure control in hypertensive patients taking multiple antihypertensive medications including fimasartan (the FORTE study). Clin Hypertens. 2020 Dec 15;26(1):24. doi: 10.1186/s40885-020-00154-y.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases