{ "FullStudy":{ "Rank":217622, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518998", "OrgStudyIdInfo":{ "OrgStudyId":"BR-FAC-CT-201" }, "Organization":{ "OrgFullName":"Boryung Pharmaceutical Co., Ltd", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Randomized, 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" }, "StatusModule":{ "StatusVerifiedDate":"June 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 29, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 1, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Boryung Pharmaceutical Co., Ltd", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Gachon University Gil Medical Center", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"The Catholic University of Korea", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Kyungpook National University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Daegu Catholic University Medical Center", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Wonkwang University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Wonju Severance Christian Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Korea University Guro Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"DongGuk University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Yeungnam University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Chonnam National University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Cheil General Hospital and Women’s Healthcare Center", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Chungnam National University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Asan Medical Center", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Seoul National University Bundang Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Inha University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Seoul National University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Inje University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Samsung Medical Center", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Busan National University Yangsan Hospital", "CollaboratorClass":"UNKNOWN" },{ "CollaboratorName":"Soon Chun Hyang University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Catholic University of Korea Saint Paul's Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Hallym University Kangnam Sacred Heart Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Jeju National University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Hanyang University Seoul Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Kangbuk Samsung Hospital", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hypertension" ] }, "KeywordList":{ "Keyword":[ "Fimasartan", "Amlodipine", "antihypertension" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Factorial Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"420", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Take one double-blind capsule filled with a placebo tablet in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Fimasartan 60mg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Take one double-blind capsule filled with of Fimasartan 60mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Fimasartan 30mg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Take one double-blind capsule filled with Fimasartan 30mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Amlodipine 5mg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Take one double-blind capsule filled with Amlodipine 5mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Amlodipine 10mg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Take one double-blind capsule filled with Amlodipine 10mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Fimasartan 60mg/ Amlodipine 5mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Fimasartan 60mg/Amlodipine 10mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Fimasartan 30mg/Amlodipine 5mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } },{ "ArmGroupLabel":"Fimasartan 30mg/Amlodipine 10mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fimasartan , Amlodipine, Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Fimasartan , Amlodipine, Placebo", "InterventionDescription":"Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Amlodipine 10mg", "Amlodipine 5mg", "Fimasartan 30mg", "Fimasartan 30mg/Amlodipine 10mg", "Fimasartan 30mg/Amlodipine 5mg", "Fimasartan 60mg", "Fimasartan 60mg/ Amlodipine 5mg", "Fimasartan 60mg/Amlodipine 10mg", "Placebo" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Kanarb", "Norvasc" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Sitting Diastolic Blood Pressure", "PrimaryOutcomeDescription":"To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit", "PrimaryOutcomeTimeFrame":"8weeks from baseline visit" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Sitting Systolic Blood Pressure", "SecondaryOutcomeDescription":"To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit", "SecondaryOutcomeTimeFrame":"at 4 and 8 weeks from Baseline visit" },{ "SecondaryOutcomeMeasure":"Sitting Diastolic Blood Pressure", "SecondaryOutcomeDescription":"To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit", "SecondaryOutcomeTimeFrame":"4weeks from baseline visit" },{ "SecondaryOutcomeMeasure":"Responder ratio", "SecondaryOutcomeDescription":"To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 8 weeks", "SecondaryOutcomeTimeFrame":"at 8weeks from baseline visit" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects who agreed to participate in this study and submitted the written informed consent\nSubjects aged 20 to 75 years\nEssential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).\nSubjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.\n\nExclusion Criteria:\n\nSevere hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)\nPatients with secondary hypertension\nPatients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication\nPatients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)\nPatients with sodium ion or body fluid is depleted and not able to correct\nPatients with hypotension who has sign and symptom\nPatients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion\nPatients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)\nPatients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)\nPatients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia\nPatients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease\nPatients with severe cerebrovascular disease\nPatients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.\nPatients with known severe or malignancy retinopathy\nPatients with hepatitis B or C or HIV positive reaction\nPatients who have a story or evidence of alcohol or drug abuse within 2years\nPatients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit\nPatients with history of allergic reaction to any angiotensin II antagonist\nPatients with any chronic inflammation disease needed to chronic inflammation therapy\nPatients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin\nChildbearing and breast-feeding women\nFemale who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods\nPatients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial\nSubject who are judged unsuitable to participate in this study by investigator", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Young Kwan Jeon, Medical Director", "OverallOfficialAffiliation":"Boryung Pharmaceutical Co., Ltd", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Samsung Medical Center", "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25850881", "ReferenceType":"derived", "ReferenceCitation":"Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 × 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 4." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000017311", "InterventionMeshTerm":"Amlodipine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" },{ "InterventionAncestorId":"D000002121", "InterventionAncestorTerm":"Calcium Channel Blockers" },{ "InterventionAncestorId":"D000049990", "InterventionAncestorTerm":"Membrane Transport Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000014665", "InterventionAncestorTerm":"Vasodilator Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M18183", "InterventionBrowseLeafName":"Amlodipine", "InterventionBrowseLeafAsFound":"Amlodipine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3966", "InterventionBrowseLeafName":"Calcium Channel Blockers", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15995", "InterventionBrowseLeafName":"Vasodilator Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"ChanBlk", "InterventionBrowseBranchName":"Channel Blockers" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006973", "ConditionMeshTerm":"Hypertension" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8607", "ConditionBrowseLeafName":"Hypertension", "ConditionBrowseLeafAsFound":"Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M1470", "ConditionBrowseLeafName":"Essential Hypertension", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }