Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00858702
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2009-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000068557', 'term': 'Olmesartan Medoxomil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hmkessler@dsi.com', 'phone': '732-590-5032', 'title': 'Howard Kessler', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Tablets and a Calcium Channel Blocker Tablet', 'description': 'olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks'}, {'id': 'OG001', 'title': 'Olmesartan Medoxomil Tablets and a Diuretic', 'description': 'olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '59.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0158', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No consideration for multiplicity', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 8', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Tablets and a Calcium Channel Blocker Tablet', 'description': 'olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks'}, {'id': 'OG001', 'title': 'Olmesartan Medoxomil Tablets and a Diuretic', 'description': 'olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0566', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No consideration for multiplicity', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 8', 'description': 'Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.'}, {'type': 'SECONDARY', 'title': 'Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olmesartan Tablets and a Calcium Channel Blocker Tablet', 'description': 'olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks'}, {'id': 'OG001', 'title': 'Olmesartan Medoxomil Tablets and a Diuretic', 'description': 'olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No consideration for multiplicity', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 8', 'description': 'Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olmesartan Tablets and a Calcium Channel Blocker Tablet', 'description': 'olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks'}, {'id': 'FG001', 'title': 'Olmesartan Medoxomil Tablets and a Diuretic Tablet', 'description': 'olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.', 'preAssignmentDetails': 'After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olmesartan Tablets and a Calcium Channel Blocker Tablet', 'description': 'olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks'}, {'id': 'BG001', 'title': 'Olmesartan Medoxomil Tablets and a Diuretic', 'description': 'olmesartan medoxomil tablets and a diuretic once daily for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2009-03-09', 'resultsFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-16', 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85', 'timeFrame': 'Baseline to week 8'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)', 'timeFrame': 'At week 8', 'description': 'Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.'}, {'measure': 'Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)', 'timeFrame': 'At week 8', 'description': 'Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Essential hypertension', 'Combination therapy'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil\n* Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil\n\nExclusion Criteria:\n\n* Patients with secondary hypertension\n* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs'}, 'identificationModule': {'nctId': 'NCT00858702', 'briefTitle': 'Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone', 'orgStudyIdInfo': {'id': 'OLM004-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks', 'interventionNames': ['Drug: olmesartan medoxomil and a CCB']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'olmesartan medoxomil and a diuretic tablet (of the thiazide class)', 'interventionNames': ['Drug: olmesartan medoxomil and a diuretic']}], 'interventions': [{'name': 'olmesartan medoxomil and a CCB', 'type': 'DRUG', 'description': 'olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks', 'armGroupLabels': ['1']}, {'name': 'olmesartan medoxomil and a diuretic', 'type': 'DRUG', 'description': 'olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Research and Development Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Yoshihiro Kakehi', 'oldOrganization': 'Daiichi Sankyo Co., Ltd.'}}}}