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

This study has been completed.

Sponsor:

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

Information provided by (Responsible Party):

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT01258673

First received: December 10, 2010

Last updated: January 2, 2012

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 10, 2010
Last Updated Date	January 2, 2012
Start Date ^ICMJE	November 2010
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 10, 2010)	Diastolic Blood Pressure [ Time Frame: 4week ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01258673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 10, 2010)	Systolic Blood Pressure / Diastolic Blood Pressure [ Time Frame: 4week, 8week / 8week ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
Official Title ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Essential Hypertension
Intervention ^ICMJE	Drug: Fimasartan/HCTZ combination Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg Drug: Fimasartan Fimasartan 60mg, 120mg
Study Arm (s)	Experimental: Fimasartan/HCTZ combination group Intervention: Drug: Fimasartan/HCTZ combination Active Comparator: Fimasartan group Intervention: Drug: Fimasartan
Publications *	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. Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	263
Completion Date	Not Provided
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Korea, Republic of
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01258673
Other Study ID Numbers ^ICMJE	BR-FHC-CT-301
Has Data Monitoring Committee	Yes
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Boryung Pharmaceutical Co., Ltd
Study Sponsor ^ICMJE	Boryung Pharmaceutical Co., Ltd
Collaborators ^ICMJE	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
Investigators ^ICMJE	Not Provided
Information Provided By	Boryung Pharmaceutical Co., Ltd
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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