A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
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ClinicalTrials.gov Identifier: NCT01258673 |
Recruitment Status
:
Completed
First Posted
: December 13, 2010
Last Update Posted
: January 5, 2012
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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
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
Tracking Information | |||
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First Submitted Date ICMJE | December 10, 2010 | ||
First Posted Date ICMJE | December 13, 2010 | ||
Last Update Posted Date | January 5, 2012 | ||
Study Start Date ICMJE | November 2010 | ||
Actual 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 |
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Condition ICMJE | Essential Hypertension | ||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
263 | ||
Original Estimated Enrollment ICMJE |
250 | ||
Study Completion Date | Not Provided | ||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 | ||
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 |
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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 |