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A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan/HCTZ combination
Fimasartan
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, Fimasartan/Hydrochlorothiazide combination

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female outpatients 18 years of age and older
  • Patients with antihypertensive agents at screening: DBP<110mmHg or Patients without antihypertensive agents at screening: DBP 90mmHg~120mmHg
  • 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
  • Patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, DBP 90mmHg~109mmHg and SBP<180mmHg

Exclusion Criteria:

  • The sitting DBP is more than 120mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
  • Patients who are measured the mean difference of mean blood pressure under SiDBP 10mmHg or SiSBP 20mmHg at screening or baseline visit
  • 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 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(include carrier)
  • 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

  • Seoul National University Hospital, Bundang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fimasartan/HCTZ combination group

Fimasartan group

Arm Description

Outcomes

Primary Outcome Measures

Diastolic Blood Pressure

Secondary Outcome Measures

Systolic Blood Pressure / Diastolic Blood Pressure

Full Information

First Posted
December 10, 2010
Last Updated
January 2, 2012
Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital, The Catholic University of Korea, Korea University Guro Hospital, DongGuk University, Seoul National University Bundang Hospital, Samsung Medical Center, Asan Medical Center, Gangnam Severance Hospital, Severance Hospital, Ajou University, Chonbuk National University Hospital, Cheil General Hospital and Women's Healthcare Center, Chonnam National University Hospital, Hanyang University, Yonsei University, Ilsan-Paik Hospital, SMG-SNU Boramae Medical Center, Kyung Hee University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01258673
Brief Title
A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
Official Title
A Randomized, Double-blind, Multicenter Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Controlled by Fimasartan 60mg(Phase 3)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital, The Catholic University of Korea, Korea University Guro Hospital, DongGuk University, Seoul National University Bundang Hospital, Samsung Medical Center, Asan Medical Center, Gangnam Severance Hospital, Severance Hospital, Ajou University, Chonbuk National University Hospital, Cheil General Hospital and Women's Healthcare Center, Chonnam National University Hospital, Hanyang University, Yonsei University, Ilsan-Paik Hospital, SMG-SNU Boramae Medical Center, Kyung Hee 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/Hydrochlorothiazide combination 60/12.5mg~120/12.5mg in patients with essential hypertension who are not controlled by fimasartan 60mg.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fimasartan/HCTZ combination group
Arm Type
Experimental
Arm Title
Fimasartan group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fimasartan/HCTZ combination
Intervention Description
Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Intervention Description
Fimasartan 60mg, 120mg
Primary Outcome Measure Information:
Title
Diastolic Blood Pressure
Time Frame
4week
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure / Diastolic Blood Pressure
Time Frame
4week, 8week / 8week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female outpatients 18 years of age and older Patients with antihypertensive agents at screening: DBP<110mmHg or Patients without antihypertensive agents at screening: DBP 90mmHg~120mmHg 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 Patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, DBP 90mmHg~109mmHg and SBP<180mmHg Exclusion Criteria: The sitting DBP is more than 120mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension Patients who are measured the mean difference of mean blood pressure under SiDBP 10mmHg or SiSBP 20mmHg at screening or baseline visit 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 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(include carrier) 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
Facility Information:
Facility Name
Seoul National University Hospital, Bundang
City
Sungnam
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26082615
Citation
Rhee MY, Baek SH, Kim W, Park CG, Park SW, Oh BH, Kim SH, Kim JJ, Shin JH, Yoo BS, Rim SJ, Ha JW, Doh JH, Ahn Y, Chae JK, Park JB, Kim SK, Kim CH. Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy. Drug Des Devel Ther. 2015 Jun 2;9:2847-54. doi: 10.2147/DDDT.S82098. eCollection 2015.
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

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A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy

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