Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-30 @ 12:17 AM
Study NCT ID:
NCT00430950
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2007-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D013607', 'term': 'Tablets'}], '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'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DataSharing@dsi.com', 'phone': '908-992-6400', 'title': 'Global Clinical Leader', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'otherDetails': 'Results of Study shall not be published without prior express written consent and approval of Sponsor. If Contractor wishes to use data generated at Sites by Investigator, such data includes but not limited to data used in collection of metrics, copy of any intended publication, details of use must be sent in writing to Quintiles and Sponsor for review. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Trough Sitting Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'OG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.16', 'spread': '8.851', 'groupId': 'OG000'}, {'value': '-10.45', 'spread': '7.928', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '0.42', 'groupDescription': 'The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.\n\nSignificance level alpha = 5%. Power = 80%.\n\nThe following statistical superiority hypothesis was tested:\n\nSuperiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.\n\nChange = Week 16 - Week 8 (baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'OG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.32', 'spread': '7.820', 'groupId': 'OG000'}, {'value': '-8.83', 'spread': '7.584', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4246', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.53', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change = Week 12 - Week 8 (baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'OG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}], 'classes': [{'title': 'Change from baseline (Week 8) to Week 16 in sBP', 'categories': [{'measurements': [{'value': '-17.41', 'spread': '13.930', 'groupId': 'OG000'}, {'value': '-17.09', 'spread': '13.126', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline (Week 8) to Week 12 in sBP', 'categories': [{'measurements': [{'value': '-14.07', 'spread': '12.654', 'groupId': 'OG000'}, {'value': '-13.80', 'spread': '12.519', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '1.24', 'estimateComment': 'refers to 8 week change; from week 8 to week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '1.21', 'estimateComment': 'refers to 4 week change; from week 8 to week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'OG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}], 'classes': [{'title': 'Change from Week 8 to Wk 16 in mean 24-hr ABPM dBP', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '8.03', 'groupId': 'OG001'}]}]}, {'title': 'Change from Week 8 to wk16 in daytime ABPM dBP', 'categories': [{'measurements': [{'value': '-9.3', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '8.48', 'groupId': 'OG001'}]}]}, {'title': 'Change from Week 8 to wk16 in nighttime ABPM dBP', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '9.49', 'groupId': 'OG001'}]}]}, {'title': 'Change from Week 8 to wk16 in mean 24-hr ABPM sBP', 'categories': [{'measurements': [{'value': '-14.7', 'spread': '13.75', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '11.81', 'groupId': 'OG001'}]}]}, {'title': 'Change from Week 8 to wk16 in daytime ABPM sBP', 'categories': [{'measurements': [{'value': '-15.0', 'spread': '14.36', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '12.45', 'groupId': 'OG001'}]}]}, {'title': 'Change from Week 8 to wk16 in nighttime ABPM sBP', 'categories': [{'measurements': [{'value': '-13.4', 'spread': '14.59', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '13.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '-0.60', 'estimateComment': '24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '-0.53', 'estimateComment': 'daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '-0.40', 'estimateComment': 'night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-3.71', 'ciUpperLimit': '-0.82', 'estimateComment': '24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-3.76', 'ciUpperLimit': '-0.76', 'estimateComment': 'daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.61', 'ciUpperLimit': '-0.48', 'estimateComment': 'night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Change = Week 16 - Week 8 (baseline).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Blood Pressure Goal.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'OG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.40', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'FG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '502'}, {'groupId': 'FG001', 'numSubjects': '508'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '489'}, {'groupId': 'FG001', 'numSubjects': '495'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'concomitant medication,etc.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners.\n\nFirst patient in: 05 December 2006 Last patient out: 07 May 2008', 'preAssignmentDetails': 'Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1010', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo'}, {'id': 'BG001', 'title': 'OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo', 'description': 'Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '404', 'groupId': 'BG000'}, {'value': '422', 'groupId': 'BG001'}, {'value': '826.0', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '168.0', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '5', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '11', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '16.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '9.67', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '9.77', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '9.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '308', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'European', 'categories': [{'measurements': [{'value': '502', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1010', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2007-02-01', 'resultsFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2007-02-01', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-13', 'studyFirstPostDateStruct': {'date': '2007-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Trough Sitting Diastolic Blood Pressure', 'timeFrame': '8 weeks', 'description': 'Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.\n\nChange = Week 16 - Week 8 (baseline).'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12', 'timeFrame': '4 weeks', 'description': 'Change = Week 12 - Week 8 (baseline).'}, {'measure': 'Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.', 'timeFrame': '8 weeks', 'description': '4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).'}, {'measure': 'Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.', 'timeFrame': '8 weeks', 'description': 'Change = Week 16 - Week 8 (baseline).'}, {'measure': 'Number of Participants Achieving Blood Pressure Goal.', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['Moderate-to-Severe Hypertension', 'Essential Hypertension', 'Combination Therapy', 'Fixed-Combination Dose'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '22114906', 'type': 'DERIVED', 'citation': 'Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)\n\nExclusion Criteria:\n\n* Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.\n* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.\n* Patients having a history of the following within the last six months:\n\n * myocardial infarction,\n * unstable angina pectoris,\n * percutaneous coronary intervention,\n * severe heart failure,\n * hypertensive encephalopathy, cerebrovascular accident (stroke) or\n * transient ischaemic attack.\n* Patients with clinically significant abnormal laboratory values at screening.\n* Patients with secondary HTN.'}, 'identificationModule': {'nctId': 'NCT00430950', 'briefTitle': 'Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy', 'orgStudyIdInfo': {'id': 'CS866CM-B-E302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo', 'interventionNames': ['Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo', 'interventionNames': ['Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg']}], 'interventions': [{'name': 'olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets', 'type': 'DRUG', 'description': 'olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks', 'armGroupLabels': ['1']}, {'name': 'olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg', 'type': 'DRUG', 'description': 'olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks', 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