Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 6:08 AM
Study NCT ID:
NCT02145104
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2014-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'C065927', 'term': 'cilnidipine'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in mean sDBP', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'change from baseline in mean sDBP', 'timeFrame': '4 weeks'}, {'measure': 'change from baseline in mean sSBP', 'timeFrame': '4, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)\n\nExclusion Criteria:\n\n* sSBP≥80mmHg after 4weeks of valsartan 160mg treatment\n* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers'}, 'identificationModule': {'nctId': 'NCT02145104', 'briefTitle': 'Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'IlDong Pharmaceutical Co Ltd'}, 'officialTitle': 'Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study', 'orgStudyIdInfo': {'id': 'ID_IDCV_1302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'cilinidpine 10mg + valsartan 160mg', 'interventionNames': ['Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'cilnidipine 5mg + valsartan 160mg', 'interventionNames': ['Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C', 'description': 'valsartan 160mg', 'interventionNames': ['Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg']}], 'interventions': [{'name': 'valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Kyung-gi', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Dong Ju Choi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IlDong Pharmaceutical Co Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}