{ "FullStudy":{ "Rank":217633, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518855", "OrgStudyIdInfo":{ "OrgStudyId":"11518" }, "Organization":{ "OrgFullName":"Bayer", "OrgClass":"INDUSTRY" }, "BriefTitle":"Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension", "OfficialTitle":"Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2004" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2005", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2005", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 26, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyOldNameTitle":"Head Medical Development Japan", "ResponsiblePartyOldOrganization":"Bayer Yakuhin Ltd." }, "LeadSponsor":{ "LeadSponsorName":"Bayer", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.\n\nTo investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hypertension" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"514", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm 1", "ArmGroupType":"Experimental", "ArmGroupDescription":"Adalat CR 20-40mg od + Diovan 40-80mg od", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Nifedipine (Adalat, BAYA1040)", "Drug: Diovan" ] } },{ "ArmGroupLabel":"Arm 2", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Norvasc 2.5-5mg od + Diovan 40-80mg od", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Amlodipine (Norvasc)", "Drug: Diovan" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Nifedipine (Adalat, BAYA1040)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1" ] } },{ "InterventionType":"Drug", "InterventionName":"Amlodipine (Norvasc)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 2" ] } },{ "InterventionType":"Drug", "InterventionName":"Diovan", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1", "Arm 2" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean treatment cost* for 16-week of double-blind treatment period", "PrimaryOutcomeDescription":"* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.", "PrimaryOutcomeTimeFrame":"16 weeks" },{ "PrimaryOutcomeMeasure":"Proportion of participants** achieving target blood pressure at the end of double-blind treatment period", "PrimaryOutcomeDescription":"**For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)", "PrimaryOutcomeTimeFrame":"at week 16" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)", "SecondaryOutcomeTimeFrame":"16 weeks" },{ "SecondaryOutcomeMeasure":"The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .", "SecondaryOutcomeTimeFrame":"baseline to week 16" },{ "SecondaryOutcomeMeasure":"Proportion of participants for each age group to target blood pressure level", "SecondaryOutcomeTimeFrame":"at week 16" },{ "SecondaryOutcomeMeasure":"Incidence of treatment-emergent drug-related adverse events", "SecondaryOutcomeTimeFrame":"16 weeks" },{ "SecondaryOutcomeMeasure":"Safety variables will be summarized using descriptive statistics based on adverse events collections", "SecondaryOutcomeTimeFrame":"16 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nUntreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:\n\nSBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)\nSBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents\n\nExclusion Criteria:\n\nPatients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.\nPatients with secondary hypertension or hypertensive emergency such as malignant hypertension.\nPatients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.\nPatients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.\nPatients with uncontrolled diabetes (HbA1c >/=8%)\nPatients with bradycardia or tachycardia (<50 bpm, >/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"79 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bayer Study Director", "OverallOfficialAffiliation":"Bayer", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Sapporo", "LocationState":"Hokkaido", "LocationZip":"060-0003", "LocationCountry":"Japan" },{ "LocationCity":"Setagaya-ku", "LocationState":"Tokyo", "LocationZip":"158-0097", "LocationCountry":"Japan" },{ "LocationCity":"Shinjuku-ku", "LocationState":"Tokyo", "LocationZip":"163-6003", "LocationCountry":"Japan" },{ "LocationCity":"Hiroshima", "LocationZip":"733-0011", "LocationCountry":"Japan" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000017311", "InterventionMeshTerm":"Amlodipine" },{ "InterventionMeshId":"D000009543", "InterventionMeshTerm":"Nifedipine" } ] }, "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" },{ "InterventionAncestorId":"D000015149", "InterventionAncestorTerm":"Tocolytic Agents" },{ "InterventionAncestorId":"D000012102", "InterventionAncestorTerm":"Reproductive Control Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M11066", "InterventionBrowseLeafName":"Nifedipine", "InterventionBrowseLeafAsFound":"Nifedipine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M301", "InterventionBrowseLeafName":"Valsartan", "InterventionBrowseLeafRelevance":"low" },{ "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" },{ "InterventionBrowseLeafId":"M16452", "InterventionBrowseLeafName":"Tocolytic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ChanBlk", "InterventionBrowseBranchName":"Channel Blockers" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006973", "ConditionMeshTerm":"Hypertension" },{ "ConditionMeshId":"D000075222", "ConditionMeshTerm":"Essential 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", "ConditionBrowseLeafAsFound":"Essential Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }