Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan

November 5, 2016 updated by: Sang Min Park, Chuncheon Sacred Heart Hospital

Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan in the Hypertensive Patient During Night and Early Morning Time

Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject don't have Anti-hypertensive drug or who stop Anti-hypertensive drug during 2 weeks
  • Office BP: over siSBP 140mmHg or si DBP 90mmHg
  • 24hr ABPM: SBP 130mmHg or DBP 80mmHg (24 hour Average)

Exclusion Criteria:

  • Pregnant, trying to become pregnant or breast feeding
  • Subject has Secondary Hypertension
  • White coat Blood Pressure (Normal result of 24 hour ABPM)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fimasartan
Fimasartan 60mg, QD
Drug: Fimasartan
Other Names:
  • Kanarb
Active Comparator: Losartan
Losartan 50mg, QD
Drug: Losartan
Other Names:
  • Cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Lowering Effect through 24 ABPM
Time Frame: 24 hour
comparing blood pressure lowering effect between night and early morning
24 hour

Collaborators and Investigators

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

Sponsor

Chuncheon Sacred Heart Hospital

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

November 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

November 5, 2016

First Submitted That Met QC Criteria

November 5, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 5, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEFILONE Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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