Comparison of Blood Pressure Lowering Effect Between Fima... | NCT02958631

Studies
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan

NCT02958631

Sponsor

Chuncheon Sacred Heart Hospital

Status

Unknown status

Last Update Posted

Nov 8, 2016Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

Fimasartan
Losartan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Nov 5, 2016

First Submission Date that Met QC Criteria

Nov 5, 2016

First Posted Date

Nov 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2016

Last Update Posted Date

Nov 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fimasartan	Experimental	Fimasartan 60mg, QD	Drug: Fimasartan
Losartan	Active Comparator	Losartan 50mg, QD	Drug: Losartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fimasartan	Drug		Fimasartan	Kanarb
Losartan

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C558933	fimasartan
D019808	Losartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided