NCT02958631

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Nov 2014

Typical duration for phase_4 hypertension

Status
unknown

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

November 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

November 5, 2016

Last Update Submit

November 5, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Lowering Effect through 24 ABPM

    comparing blood pressure lowering effect between night and early morning

    24 hour

Study Arms (2)

Fimasartan

EXPERIMENTAL

Fimasartan 60mg, QD

Drug: Fimasartan

Losartan

ACTIVE COMPARATOR

Losartan 50mg, QD

Drug: Losartan

Interventions

FimasartanDRUG
Also known as: Kanarb
Fimasartan
LosartanDRUG
Also known as: Cozaar
Losartan

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • hr ABPM: SBP 130mmHg or DBP 80mmHg (24 hour Average)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

fimasartanLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 5, 2016

First Posted

November 8, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share