Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-04 @ 4:05 AM
Study NCT ID:
NCT01355367
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose BAYA1040 CR: a Long Term Extension 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-05-17', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables will be summarized using descriptive statistics based on adverse events collection', 'timeFrame': 'Week 52'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in diastolic blood pressure (DBP) while sitting', 'timeFrame': 'Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52'}, {'measure': 'Changes from baseline in systolic blood pressure (SBP) while sitting', 'timeFrame': 'Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52'}, {'measure': 'Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines', 'timeFrame': 'Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52'}, {'measure': 'Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP', 'timeFrame': 'Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BAYA1040 CR', 'Nifedipine', 'Essential hypertension', 'Japanese Patients', 'Phase III', 'Extension study'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable\n\nExclusion Criteria:\n\n* Patients with expected difficulties for the continuous 1 year follow up'}, 'identificationModule': {'nctId': 'NCT01355367', 'briefTitle': 'High Dose BAYA1040 CR: a Long Term Extension Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)', 'orgStudyIdInfo': {'id': '14023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Nifedipine (Adalat, BAYA1040)']}], 'interventions': [{'name': 'Nifedipine (Adalat, BAYA1040)', 'type': 'DRUG', 'description': 'BAYA1040 CR 40mg BID', 'armGroupLabels': ['Arm 1']}]}, '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'}}}}