NCT03254914

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

August 17, 2017

Last Update Submit

December 23, 2024

Conditions

Hypertension

Keywords

Home Blood PressureFimasartan

Outcome Measures

Primary Outcomes (1)

  • Rate of reaching target blood pressure

    Rate of reaching target blood pressure after treatment for 12 weeks

    12 weeks after treatment

Study Arms (2)

Control Site

Measure Clinic Blood Pressure

Test Site

Measure Clinic Blood Pressure and Home Blood Pressure

Procedure: Home Blood Pressure

Interventions

Home Blood PressurePROCEDURE

Measure Home Blood Pressure

Test Site

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertensive patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33317628DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 21, 2017

Study Start

August 9, 2017

Primary Completion

October 31, 2018

Study Completion

February 28, 2019

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)