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NCT03254914 Clinical Trial

Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study

Hypertension Clinical Trial

Official title:
A Multi-center, Cluster-randomized, Prospective, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03254914
Other study ID # BR-FMS-OS-403
Secondary ID
Status Recruiting
Phase N/A
First received August 17, 2017
Last updated August 17, 2017
Start date August 9, 2017
Est. completion date September 30, 2019

Study information
Verified date August 2017
Source Boryung Pharmaceutical Co., Ltd
Contact Hyung-jin Jung, MD
Phone 82-2-708-8233
Email hjjung@boryung.co.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 4320
Est. completion date September 30, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Home Blood Pressure
Measure Home Blood Pressure

Locations
Country Name City State
Korea, Republic of Seoul national university hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of reaching target blood pressure Rate of reaching target blood pressure after treatment for 12 weeks 12 weeks after treatment
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