Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study

August 17, 2017 updated by: Boryung Pharmaceutical Co., Ltd

A Multi-center, Cluster-randomized, Prospective, Observational Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

4320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hae-young Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hypertensive patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Site
Measure Clinic Blood Pressure
Test Site
Measure Clinic Blood Pressure and Home Blood Pressure
Procedure: Home Blood Pressure
Measure Home Blood Pressure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Hae-young Lee, MD, Seoul National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2017

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-FMS-OS-403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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