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Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K) (Fimasartan)

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
Fimasartan (BR-A-657•K) 20 mg
Fimasartan (BR-A-657•K) 60 mg
Fimasartan (BR-A-657•K) 180 mg
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult men and women, aged 18 - 65
  • Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg
  • Patients who gave their consent to participate in this study and signed the written informed consent form
  • Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date

Exclusion Criteria:

  1. Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
  2. Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
  3. Patients with secondary hypertension
  4. Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
  5. Patients with symptoms of orthostatic hypotension
  6. Patients with severe insulin dependent diabetes or uncontrolled diabetes
  7. Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease
  8. Patients with consumption disease, autoimmune disease, or connective tissue disease
  9. Patients with the history of type B hepatitis or type C hepatitis
  10. Patients with HIV infection or hepatitis
  11. Patients with clinically significant abnormal laboratory test findings
  12. Patients on any drug treatment that might affect the blood pressure
  13. Patients with allergy or contraindication to angiotensin II-receptor antagonists
  14. Patients with current or suspected alcohol addiction or history of drug abuse
  15. Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table
  16. Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo

    BR-A-657•K 20 mg group

    BR-A-657•K 60 mg group

    BR-A-657•K 180 mg group

    Arm Description

    Placebo, 3 tablets

    Fimasartan 20 mg, 1 tablet + placebo, 2 tablets

    Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet

    Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet

    Outcomes

    Primary Outcome Measures

    the level of sitting diastolic blood pressure reduction

    Secondary Outcome Measures

    the level of sitting systolic blood pressure reduction, mean blood pressure (MBP), 24-hr day-time, night-time SBP and DBP, T/P ratio based on the 24-hr Ambulatory Blood Pressure Monitoring

    Full Information

    First Posted
    July 10, 2009
    Last Updated
    July 10, 2009
    Sponsor
    Boryung Pharmaceutical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00937651
    Brief Title
    Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)
    Acronym
    Fimasartan
    Official Title
    Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2005 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Boryung Pharmaceutical Co., Ltd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Study objective: To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension. To review the pharmacokinetic profile after the multiple administration and the pharmacodynamic profile regarding the renin-angiotensin system, after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension. To determine the dose for the clinical study at the next phase by analyzing the relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic results.
    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 60 patients will be enrolled over 12 months in Seoul National University Hospital. After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. Subjects will take test drug/placebo for 28 days 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 180 mg

    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, 3 tablets
    Arm Title
    BR-A-657•K 20 mg group
    Arm Type
    Active Comparator
    Arm Description
    Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
    Arm Title
    BR-A-657•K 60 mg group
    Arm Type
    Active Comparator
    Arm Description
    Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
    Arm Title
    BR-A-657•K 180 mg group
    Arm Type
    Active Comparator
    Arm Description
    Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Fimasartan (BR-A-657•K) 20 mg
    Other Intervention Name(s)
    Fimasartan
    Intervention Description
    Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Fimasartan (BR-A-657•K) 60 mg
    Other Intervention Name(s)
    Fimasartan
    Intervention Description
    Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Fimasartan (BR-A-657•K) 180 mg
    Other Intervention Name(s)
    Fimasartan
    Intervention Description
    Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
    Primary Outcome Measure Information:
    Title
    the level of sitting diastolic blood pressure reduction
    Time Frame
    Day -1 vs Day 27
    Secondary Outcome Measure Information:
    Title
    the level of sitting systolic blood pressure reduction, mean blood pressure (MBP), 24-hr day-time, night-time SBP and DBP, T/P ratio based on the 24-hr Ambulatory Blood Pressure Monitoring
    Time Frame
    Day -1 vs Day 27

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult men and women, aged 18 - 65 Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg Patients who gave their consent to participate in this study and signed the written informed consent form Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date Exclusion Criteria: Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures. Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg Patients with secondary hypertension Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs Patients with symptoms of orthostatic hypotension Patients with severe insulin dependent diabetes or uncontrolled diabetes Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease Patients with consumption disease, autoimmune disease, or connective tissue disease Patients with the history of type B hepatitis or type C hepatitis Patients with HIV infection or hepatitis Patients with clinically significant abnormal laboratory test findings Patients on any drug treatment that might affect the blood pressure Patients with allergy or contraindication to angiotensin II-receptor antagonists Patients with current or suspected alcohol addiction or history of drug abuse Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator

    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
    derived

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    Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)

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