A Randomazed, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension
This study is currently recruiting participants.
Verified January 2012 by Boryung Pharmaceutical Co., Ltd
Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborators:
Gachon University Gil Medical Center
The Catholic University of Korea
Gyungbook national university hospital
Gyemyung university hospital
Daegu Catholic university hospital
Wonkwang university Hospital
Yonsei University Wonjoo Christian Hospital
Korea University Guro Hospital
DongGuk University Ilsan Hospital
Yeungnam University
Chonnam National University Hospital
Cheil General Hospital and Women’s Healthcare Center
Chungnam National University
Asan Medical Center
Seoul National University Bundang Hospital
Inha University Hospital
Seoul National University Hospital
Inje University Busan Beak Hospital
Samsung Medical Center
Busan university Yangsan Hospital
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01518998
First received: January 24, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
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First Received Date ICMJE | January 24, 2012 | ||||||||
Last Updated Date | January 24, 2012 | ||||||||
Start Date ICMJE | August 2011 | ||||||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Sitting Diastolic Blood Pressure [ Time Frame: 8weeks from baseline visit ] [ Designated as safety issue: Yes ] To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Randomazed, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension | ||||||||
Official Title ICMJE | |||||||||
Brief Summary | The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan |
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Detailed Description | |||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | ||||||||
Intervention ICMJE | Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
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Study Arm (s) |
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Publications * | |||||||||
* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 405 | ||||||||
Estimated Completion Date | October 2012 | ||||||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 20 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Korea, Republic of | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01518998 | ||||||||
Other Study ID Numbers ICMJE | BR-FAC-CT-201 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Boryung Pharmaceutical Co., Ltd | ||||||||
Study Sponsor ICMJE | Boryung Pharmaceutical Co., Ltd | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Boryung Pharmaceutical Co., Ltd | ||||||||
Verification Date | January 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |