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

Diastolic Blood Pressure [ Time Frame: 4week ]

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

Systolic Blood Pressure / Diastolic Blood Pressure [ Time Frame: 4week, 8week / 8week ]

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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Arms

Experimental: Fimasartan/HCTZ combination group
Intervention: Drug: Fimasartan/HCTZ combination
Active Comparator: Fimasartan group
Intervention: Drug: Fimasartan

Publications *

* 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

PRS Account

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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