Back to resultsComparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fimasartan
Losartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fimasartan
Losartan
Arm Description
Fimasartan 60mg, QD
Losartan 50mg, QD
Outcomes
Primary Outcome Measures
Blood Pressure Lowering Effect through 24 ABPM
comparing blood pressure lowering effect between night and early morning
Secondary Outcome Measures
Full Information
NCT ID
NCT02958631
First Posted
November 5, 2016
Last Updated
November 5, 2016
Sponsor
Chuncheon Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02958631
Brief Title
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan
Official Title
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan in the Hypertensive Patient During Night and Early Morning Time
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fimasartan
Arm Type
Experimental
Arm Description
Fimasartan 60mg, QD
Arm Title
Losartan
Arm Type
Active Comparator
Arm Description
Losartan 50mg, QD
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Other Intervention Name(s)
Kanarb
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Cozaar
Primary Outcome Measure Information:
Title
Blood Pressure Lowering Effect through 24 ABPM
Description
comparing blood pressure lowering effect between night and early morning
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan
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