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The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Fimasartan 60mg

Fimasartan 120mg

Candesartan cilexetil

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, ARB, Fimasartan

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who agreed to participate in this study and submitted the written informed consent
Subjects aged 19 to 75 years
Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

Exclusion Criteria:

Severe hypertension patients; more 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
Patients with secondary hypertension
Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
Patients with hypotension who has sign and symptom
Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
Patients with severe cerebrovascular disease
Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
Patients with known severe or malignancy retinopathy
Patients with hepatitis B or C or HIV positive reaction
Patients who have a story or evidence of alcohol or drug abuse within 2years
Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
Patients with history of allergic reaction to any angiotensin II antagonist
Patients with any chronic inflammation disease needed to chronic inflammation therapy
Childbearing and breast-feeding women
Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
Subject who are judged unsuitable to participate in this study by investigator

Sites / Locations

KyungPook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Fimasartan 60mg

Fimasartan 120mg

Candesartan 8mg

Arm Description

Take one tablet of Fimasartan 60mg once a day in the morning

Take one tablet of Fimasartan 120mg once a day in the morning

Take one tablet of Candesartan 8mg once a day in the morning

Outcomes

Primary Outcome Measures

Sitting Diastolic Blood Pressure

To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg

Secondary Outcome Measures

Sitting DBP

To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg

SittingDBP

To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg

Sitting Systolic Blood Pressure

To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg

Responder ratio

To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg

Full Information

NCT ID

NCT01135212

First Posted

May 31, 2010

Last Updated

August 22, 2012

Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Kyungpook National University Hospital, Gyeongsang National University Hospital, Keimyung University, Kosin University Gospel Hospital, Daegu Catholic University Medical Center, Dong-A medical center, Pusan National University Yangsan Hospital, Yeungnam University Hospital, Ulsan University Hospital, Inje University, Pusan National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01135212

Brief Title

The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

Official Title

A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.

Detailed Description

A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit. During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension, ARB, Fimasartan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fimasartan 60mg

Arm Type

Active Comparator

Arm Description

Take one tablet of Fimasartan 60mg once a day in the morning

Arm Title

Fimasartan 120mg

Arm Type

Active Comparator

Arm Description

Take one tablet of Fimasartan 120mg once a day in the morning

Arm Title

Candesartan 8mg

Arm Type

Active Comparator

Arm Description

Take one tablet of Candesartan 8mg once a day in the morning

Intervention Type

Drug

Intervention Name(s)

Fimasartan 60mg

Intervention Description

Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.

Intervention Type

Drug

Intervention Name(s)

Fimasartan 120mg

Intervention Description

Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.

Intervention Type

Drug

Intervention Name(s)

Candesartan cilexetil

Other Intervention Name(s)

Atacand 8mg

Intervention Description

Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.

Primary Outcome Measure Information:

Title

Sitting Diastolic Blood Pressure

Description

To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg

Time Frame

12weeks from baseline visit

Secondary Outcome Measure Information:

Title

Sitting DBP

Description

To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg

Time Frame

at 12weeks from Baseline visit

Title

SittingDBP

Description

To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg

Time Frame

at 4, 8 weeks from baseline visit

Title

Sitting Systolic Blood Pressure

Description

To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg

Time Frame

at 4,8,12 weeks from baseline visit

Title

Responder ratio

Description

To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg

Time Frame

at 12weeks from baseline visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who agreed to participate in this study and submitted the written informed consent Subjects aged 19 to 75 years Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0). Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period. Exclusion Criteria: Severe hypertension patients; more 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP) Patients with secondary hypertension Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication Patients with hypotension who has sign and symptom Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin) Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG) Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease Patients with severe cerebrovascular disease Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous. Patients with known severe or malignancy retinopathy Patients with hepatitis B or C or HIV positive reaction Patients who have a story or evidence of alcohol or drug abuse within 2years Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit Patients with history of allergic reaction to any angiotensin II antagonist Patients with any chronic inflammation disease needed to chronic inflammation therapy Childbearing and breast-feeding women Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial Subject who are judged unsuitable to participate in this study by investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ShungChull Chae, Doctor´s degree

Organizational Affiliation

KuyngPook National Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

KyungPook National University Hospital

City

Daegu

ZIP/Postal Code

110-750

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

27161546

Citation

Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, Kim MH, Chun KJ, Cha GS, Hong GR, Lee SG, Kim DS, Kim DI, Chae SC. A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension. Clin Ther. 2016 Jun;38(6):1485-1497. doi: 10.1016/j.clinthera.2016.04.005. Epub 2016 May 6.

Results Reference

derived

PubMed Identifier

21740078

Citation

Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.

Results Reference

derived

Learn more about this trial

The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

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