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A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Primary Purpose

Essential Hypertension

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Fimasartan 60 mg group

Fimasartan 120 mg group

Reference (Valsartan 80 mg) group

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Fimasartan, Essential Hypertension, 24hour ABPM, Population PK

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg.
Subjects who agree to participate in this sudy and give written informed consent
Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

Exclusion Criteria:

The sitting DBP is less than 89mmHg or more than 110mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
Patients with postural hypotension
Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening)
Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
Patients with consumptive disease, autoimmune disease, connective tissue disease
Patients with a history of type B or C hepatitis
Patients with HIV or hepatitis
Patients with clinically significant laboratory abnormality
Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
Patients with allergy or contraindication to any angiotensin II receptor antagonists
Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
Patients judged to have a history of alcohol or drug abuse by the investigator
Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Fimasartan 1

Fimasartan 2

Valsartan

Arm Description

Fimasartan 60 mg group

Fimasartan 120 mg group

Reference (Valsartan 80 mg) group

Outcomes

Primary Outcome Measures

Mean Change of Diastolic Blood Pressure

24hr Mean change of DBP on Week 8, from Baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT00922441

First Posted

June 16, 2009

Last Updated

February 19, 2018

Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Seoul National University Hospital, Kyungpook National University Hospital, Catholic Medical Center, Inje University, Chonnam National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00922441

Brief Title

A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Official Title

A Randomized, Double-blind, Valsartan-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) During 24hours by Dose in Patients With Mild to Moderate Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Seoul National University Hospital, Kyungpook National University Hospital, Catholic Medical Center, Inje University, Chonnam National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.

Detailed Description

Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose. A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during 24hoursby dose in Patients with Mild to Moderate Essential Hypertension. Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide. After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period. Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg group

6. Conditions and Keywords

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

Essential Hypertension

Keywords

Fimasartan, Essential Hypertension, 24hour ABPM, Population PK

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fimasartan 1

Arm Type

Experimental

Arm Description

Fimasartan 60 mg group

Arm Title

Fimasartan 2

Arm Type

Experimental

Arm Description

Fimasartan 120 mg group

Arm Title

Valsartan

Arm Type

Active Comparator

Arm Description

Reference (Valsartan 80 mg) group

Intervention Type

Drug

Intervention Name(s)

Fimasartan 60 mg group

Other Intervention Name(s)

BR-A-657.K

Intervention Description

Fimasartan 60 mg

Intervention Type

Drug

Intervention Name(s)

Fimasartan 120 mg group

Other Intervention Name(s)

BR-A-657.K

Intervention Description

Fimasartan 120 mg

Intervention Type

Drug

Intervention Name(s)

Reference (Valsartan 80 mg) group

Other Intervention Name(s)

Diovan

Intervention Description

Reference (Valsartan 80 mg)

Primary Outcome Measure Information:

Title

Mean Change of Diastolic Blood Pressure

Description

24hr Mean change of DBP on Week 8, from Baseline

Time Frame

baseline and 8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg. Subjects who agree to participate in this sudy and give written informed consent Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study Exclusion Criteria: The sitting DBP is less than 89mmHg or more than 110mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug Patients with postural hypotension Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening) Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months Patients with consumptive disease, autoimmune disease, connective tissue disease Patients with a history of type B or C hepatitis Patients with HIV or hepatitis Patients with clinically significant laboratory abnormality Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure Patients with allergy or contraindication to any angiotensin II receptor antagonists Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal Patients judged to have a history of alcohol or drug abuse by the investigator Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons

Overall Study Officials: