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Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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 Screening and Baseline(Day1) are 95~114 mmHg inclusive and the difference between sitting diastolic blood pressures measured at Day -14 and Baseline(Day1) 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 94mmHg or more than 115mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg
  • Patients with secondary hypertension
  • Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), 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 3 months, 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 with average weight > +35% or <-15% in Modified Metropolitan Life Insurance table
  • Patients participated other clinical trial 3 months before Screening
  • Patients judged to be inappropriate for this study by the investigator with other reasons

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Fimasartan 20mg

Fimasartan 60mg

Fimasartan 120mg

Fimasartan 240mg

Arm Description

3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks

2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks

3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks

3 tablets of fimasartan 40mg will be taken 30minutes after breakfast

3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks

Outcomes

Primary Outcome Measures

change from baseline to end of 8 week treatment in sitting diastolic blood pressure

Secondary Outcome Measures

change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure
change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure
responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg

Full Information

First Posted
June 16, 2009
Last Updated
June 17, 2009
Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Seoul National University Bundang Hospital, The Catholic University of Korea, Severance Hospital, Yonsei University, Cheil General Hospital and Women's Healthcare Center
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1. Study Identification

Unique Protocol Identification Number
NCT00923611
Brief Title
Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Grouped, Clinical Study to Evaluate the Antihypertensive Efficacy and Tolerability and to Determine the Adequate Antihypertensive Dosage of Fimasartan(BR-A-657-K) in Patients With Mild to Moderate Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Seoul National University Bundang Hospital, The Catholic University of Korea, Severance Hospital, Yonsei University, Cheil General Hospital and Women's Healthcare Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with mild to moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.
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, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension. Approximately 182 patients will be enrolled over 12 months in 8 centers nationwide. After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 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 : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 120 mg, Group V : Fimasartan 240 mg,

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks
Arm Title
Fimasartan 20mg
Arm Type
Active Comparator
Arm Description
2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
Arm Title
Fimasartan 60mg
Arm Type
Active Comparator
Arm Description
3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
Arm Title
Fimasartan 120mg
Arm Type
Active Comparator
Arm Description
3 tablets of fimasartan 40mg will be taken 30minutes after breakfast
Arm Title
Fimasartan 240mg
Arm Type
Active Comparator
Arm Description
3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Primary Outcome Measure Information:
Title
change from baseline to end of 8 week treatment in sitting diastolic blood pressure
Time Frame
8 week from baseline
Secondary Outcome Measure Information:
Title
change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure
Time Frame
2, 4 week from baseline
Title
change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure
Time Frame
2,4,8 week from baseline
Title
responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg
Time Frame
8 week from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Screening and Baseline(Day1) are 95~114 mmHg inclusive and the difference between sitting diastolic blood pressures measured at Day -14 and Baseline(Day1) 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 94mmHg or more than 115mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), 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 3 months, 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 with average weight > +35% or <-15% in Modified Metropolitan Life Insurance table Patients participated other clinical trial 3 months before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Hee Oh, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jae-Joong Kim, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eun-Suk Jeon, Professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki-Bae Seong, Professor
Organizational Affiliation
Kangnam ST.Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong-Won Ha, Professor
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Se-Joong Lim, Professor
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong-Bae Park, Professor
Organizational Affiliation
Cheil General Hospital and Women's Healthcare Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22608107
Citation
Lee H, Yang HM, Lee HY, Kim JJ, Choi DJ, Seung KB, Jeon ES, Ha JW, Rim SJ, Park JB, Shin JH, Oh BH. Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg/d in Korean Patients with hypertension: findings from Two Phase II, randomized, double-blind, placebo-controlled studies. Clin Ther. 2012 Jun;34(6):1273-89. doi: 10.1016/j.clinthera.2012.04.021. Epub 2012 May 17. Erratum In: Clin Ther. 2012 Sep;34(9):2020.
Results Reference
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Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

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