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Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan

Sponsor
Chuncheon Sacred Heart Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02958631
Collaborator
(none)
40
Enrollment
2
Arms
29
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan in the Hypertensive Patient During Night and Early Morning Time
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fimasartan

Fimasartan 60mg, QD

Drug: Fimasartan
Other Names:
  • Kanarb

    		•
    Active Comparator: Losartan

    Losartan 50mg, QD

    Drug: Losartan
    Other Names:
  • Cozaar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood Pressure Lowering Effect through 24 ABPM [24 hour]

      comparing blood pressure lowering effect between night and early morning

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chuncheon Sacred Heart Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sang Min Park, MD, Chuncheon Sacred Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT02958631
    Other Study ID Numbers:
    • CEFILONE Study
    First Posted:
    Nov 8, 2016
    Last Update Posted:
    Nov 8, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hypertension
    Losartan

    Study Results

    No Results Posted as of Nov 8, 2016