Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:13 PM
Study NCT ID:
NCT01287260
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2011-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose BAYA1040_Nifedipine: a Dose-comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009543', 'term': 'Nifedipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2011-01-30', 'studyFirstSubmitQcDate': '2011-01-30', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy changes measured by sitting diastolic blood pressure (DBP)', 'timeFrame': 'Up to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy changes measured by sitting systolic blood pressure (SBP)', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP', 'timeFrame': 'Up to 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BAYA1040_Nifedipine', 'Nifedipine', 'Essential hypertension', 'Japanese Patients', 'Phase III', '13176'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '23945965', 'type': 'DERIVED', 'citation': 'Shimamoto K, Hasebe N, Ito S, Kario K, Kimura K, Dohi Y, Kawano Y, Rakugi H, Horiuchi M, Imaizumi T, Ohya Y. Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study. Hypertens Res. 2014 Jan;37(1):69-75. doi: 10.1038/hr.2013.80. Epub 2013 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040\\_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040\\_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040\\_Nifedipine 40 mg once daily treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years or older\n* Japanese male or female\n* Outpatient with essential hypertension\n* Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug\n\nExclusion Criteria:\n\n* Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more\n* Patients with secondary hypertension or hypertensive emergency'}, 'identificationModule': {'nctId': 'NCT01287260', 'briefTitle': 'High Dose BAYA1040_Nifedipine: a Dose-comparative Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient', 'orgStudyIdInfo': {'id': '13176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1', 'interventionNames': ['Drug: Nifedipine (Adalat, BAYA1040)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Nifedipine (Adalat, BAYA1040)']}], 'interventions': [{'name': 'Nifedipine (Adalat, BAYA1040)', 'type': 'DRUG', 'description': 'BAYA1040\\_Nifedipine 40mg twice daily (BID)', 'armGroupLabels': ['Arm1']}, {'name': 'Nifedipine (Adalat, BAYA1040)', 'type': 'DRUG', 'description': 'BAYA1040\\_Nifedipine 40mg once daily (OD)', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '036-8082', 'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'zip': '273-0100', 'city': 'Kamagaya', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.76971, 'lon': 140.00238}}, {'zip': '070-0061', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '078-8214', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '003-0026', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '003-0825', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '004-0004', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '007-0841', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '062-0053', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0841', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '064-0803', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '064-0807', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '210-0852', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '574-0074', 'city': 'Daitō', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.71378, 'lon': 135.62033}}, {'zip': '596-8522', 'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'zip': '581-0011', 'city': 'Yao', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.61667, 'lon': 135.6}}, {'zip': '359-1141', 'city': 'Tokorozawa', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'zip': '421-0193', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '192-0046', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '152-0031', 'city': 'Meguro City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6322, 'lon': 139.70174}}, {'zip': '105-7390', 'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}, {'zip': '108-0075', 'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}