Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-02 @ 2:42 AM
Study NCT ID:
NCT05170061
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
24 Hour Ambulatory Cardiac Oxygen Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000068577', 'term': 'Nebivolol'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jizzo@buffalo.edu', 'phone': '7168985625', 'title': 'Joseph Izzo MD', 'organization': 'SUNYBuffalo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Relatively small sample size limits extrapolation. Small number of non-blacks precludes racial stratification.'}}, 'adverseEventsModule': {'timeFrame': '15 weeks for each participant; approximately 1-year for the study overall', 'description': 'same definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2531', 'spread': '400', 'groupId': 'OG000'}, {'value': '2824', 'spread': '530', 'groupId': 'OG001'}, {'value': '2484', 'spread': '368', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'see above', 'groupDescription': 'Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \\< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired analysis'}], 'paramType': 'MEAN', 'timeFrame': 'measurement after 4 weeks in each treatment arm', 'description': 'ACRPP is the product of estimated aortic mean systolic pressure (mean aortic pressure estimated using a transfer function applied to brachial cuff blood pressure) during the systolic time interval adjusted for heart rate. Units are (mmHg\\*beats/min).', 'unitOfMeasure': 'mmHg*beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each group represents total number who received that treatment arm (n=26) given randomly in 6 possible sequences: N-V-N/V, N-N/V-V, V-N-N/V, V-N/V-N, N/V-N-V, N/V-V-N) Design was used to minimize any potential carryover bias from prior treatment, in part because of the relatively short duration of each treatment and the absence of washout periods between arms.'}, {'type': 'SECONDARY', 'title': 'Cuff SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '17', 'groupId': 'OG000'}, {'value': '148', 'spread': '17', 'groupId': 'OG001'}, {'value': '146', 'spread': '20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Seated office cuff systolic blood pressure (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cuff DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '12', 'groupId': 'OG000'}, {'value': '87', 'spread': '13', 'groupId': 'OG001'}, {'value': '81', 'spread': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Seated office cuff diastolic blood pressure (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Ambulatory Brachial Double Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9329', 'spread': '1572', 'groupId': 'OG000'}, {'value': '11239', 'spread': '2336', 'groupId': 'OG001'}, {'value': '9154', 'spread': '1607', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': '24-hour mean heart rate x 24-hour mean systolic BP', 'unitOfMeasure': 'mmHg*beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Ambulatory Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '8', 'groupId': 'OG000'}, {'value': '77', 'spread': '16', 'groupId': 'OG001'}, {'value': '63', 'spread': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean heart rate over 24 hours', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Ambulatory Mean Central Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '13', 'groupId': 'OG000'}, {'value': '90', 'spread': '12', 'groupId': 'OG001'}, {'value': '89', 'spread': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory aortic (central) diastolic pressure over 24 hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': '24-hour Brachial Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'spread': '15', 'groupId': 'OG000'}, {'value': '143', 'spread': '16', 'groupId': 'OG001'}, {'value': '145', 'spread': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean 24-hour ambulatory systolic BP', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': '24-hour Brachial Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'spread': '12', 'groupId': 'OG000'}, {'value': '88', 'spread': '12', 'groupId': 'OG001'}, {'value': '87', 'spread': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean 24-hour ambulatory cuff diastolic BP', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2482', 'spread': '368', 'groupId': 'OG000'}, {'value': '2817', 'spread': '394', 'groupId': 'OG001'}, {'value': '2423', 'spread': '390', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Determined by ambulatory heart rate-central systolic pressure product during self-reported waking hours at the end of each study phase', 'unitOfMeasure': 'mmHg*beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Nighttime ACRPP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2454', 'spread': '471', 'groupId': 'OG000'}, {'value': '2564', 'spread': '516', 'groupId': 'OG001'}, {'value': '2309', 'spread': '446', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours', 'unitOfMeasure': 'mmHg*beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Daytime Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '10', 'groupId': 'OG000'}, {'value': '81', 'spread': '13', 'groupId': 'OG001'}, {'value': '64', 'spread': '9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory heart rate during self-reported waking hours', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Nighttime Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '9', 'groupId': 'OG000'}, {'value': '74', 'spread': '12', 'groupId': 'OG001'}, {'value': '63', 'spread': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory heart rate during self-reported sleeping hours', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Daytime Central Systolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'spread': '11', 'groupId': 'OG000'}, {'value': '135', 'spread': '14', 'groupId': 'OG001'}, {'value': '136', 'spread': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory central systolic pressure during self-reported waking hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Nighttime Central Systolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'spread': '20', 'groupId': 'OG000'}, {'value': '130', 'spread': '19', 'groupId': 'OG001'}, {'value': '131', 'spread': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory central systolic pressure during self-reported sleeping hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Daytime Brachial Systolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'spread': '12', 'groupId': 'OG000'}, {'value': '146', 'spread': '15', 'groupId': 'OG001'}, {'value': '147', 'spread': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory brachial systolic pressure during self-reported waking hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Nighttime Brachial Systolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'spread': '21', 'groupId': 'OG000'}, {'value': '138', 'spread': '19', 'groupId': 'OG001'}, {'value': '141', 'spread': '17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory brachial systolic pressure during self-reported sleeping hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Daytime Central Diastolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'spread': '11', 'groupId': 'OG000'}, {'value': '93', 'spread': '12', 'groupId': 'OG001'}, {'value': '92', 'spread': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory central diastolic pressure during self-reported waking hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Nighttime Central Diastolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'spread': '15', 'groupId': 'OG000'}, {'value': '86', 'spread': '15', 'groupId': 'OG001'}, {'value': '85', 'spread': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory central diastolic pressure during self-reported sleeping hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Daytime Brachial Diastolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '10', 'groupId': 'OG000'}, {'value': '91', 'spread': '11', 'groupId': 'OG001'}, {'value': '89', 'spread': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory brachial diastolic pressure during self-reported waking hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Nighttime Brachial Diastolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '16', 'groupId': 'OG000'}, {'value': '83', 'spread': '14', 'groupId': 'OG001'}, {'value': '83', 'spread': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory brachial diastolic pressure during self-reported sleeping hours', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Ambulatory Daytime Brachial Rate-pressure Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9528', 'spread': '1530', 'groupId': 'OG000'}, {'value': '11869', 'spread': '2265', 'groupId': 'OG001'}, {'value': '9335', 'spread': '1607', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours', 'unitOfMeasure': 'mmHg*beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Ambulatory Nighttime Brachial Rate-pressure Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'OG002', 'title': 'Nebivolol/Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9284', 'spread': '1920', 'groupId': 'OG000'}, {'value': '10338', 'spread': '2449', 'groupId': 'OG001'}, {'value': '8830', 'spread': '1827', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'see primary dependent variable', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'see primary dependent variable'}], 'paramType': 'MEAN', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours', 'unitOfMeasure': 'mmHg*beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: Nebivolol, Valsartan, Combination Nebivolol/Valsartan', 'description': 'Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week), then Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week).'}, {'id': 'FG001', 'title': 'Sequence 2: Nebivolol, Combination Nebivolol/Valsartan, Valsartan', 'description': 'Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week); Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week)'}, {'id': 'FG002', 'title': 'Sequence 3: Valsartan, Nebivolol, Combination Nebivolol/Valsartan', 'description': 'Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week), Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week).'}, {'id': 'FG003', 'title': 'Sequence 4: Valsartan, Combination Nebivolol/Valsartan, Nebivolol', 'description': 'Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week); Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week),'}, {'id': 'FG004', 'title': 'Sequence 5: Combination Nebivolol/Valsartan, Nebivolol, Valsartan', 'description': 'Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week);'}, {'id': 'FG005', 'title': 'Sequence 6: Combination Nebivolol/Valsartan, Valsartan, Nebivolol', 'description': 'Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week),'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the practice of the investigator and by advertisement', 'preAssignmentDetails': 'Males and females, 18 years or older with chronic hypertension, treated or untreated, were eligible if their seated mean clinic systolic BP was 145-179 mm Hg, inclusive, or clinic diastolic BP 92-119 mm Hg, inclusive. Prior antihypertensive drug therapy was discontinued prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1: Nebivolol, Valsartan, Nebivolol/Valsartan', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}, {'id': 'BG001', 'title': 'Sequence 2: Nebivolol, Nebivolol/Valsartan, Valsartan', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'BG002', 'title': 'Sequence 3: Valsartan, Nebivolol, Nebivolol/Valsartan', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily'}, {'id': 'BG003', 'title': 'Sequence 4: Valsartan, Nebivolol/Valsartan, Nebivolol', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'BG004', 'title': 'Sequence 5: Nebivolol/Valsartan, Nebivolol, Valsartan', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily'}, {'id': 'BG005', 'title': 'Sequence 6: Nebivolol/Valsartan, Valsartan, Nebivolol', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '10', 'groupId': 'BG000'}, {'value': '56', 'spread': '9', 'groupId': 'BG001'}, {'value': '59', 'spread': '10', 'groupId': 'BG002'}, {'value': '57', 'spread': '9', 'groupId': 'BG003'}, {'value': '56', 'spread': '11', 'groupId': 'BG004'}, {'value': '59', 'spread': '11', 'groupId': 'BG005'}, {'value': '58', 'spread': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded: drugs formulated into capsules by an outside research pharmacist who held the codes until study completion'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Random-order-entry 3-way crossover of active treatments; all participants receive all 3 active treatments with 6 possible experimental sequences (arms)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2014-12-22', 'resultsFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-21', 'studyFirstPostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)', 'timeFrame': 'measurement after 4 weeks in each treatment arm', 'description': 'ACRPP is the product of estimated aortic mean systolic pressure (mean aortic pressure estimated using a transfer function applied to brachial cuff blood pressure) during the systolic time interval adjusted for heart rate. Units are (mmHg\\*beats/min).'}], 'secondaryOutcomes': [{'measure': 'Cuff SBP', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Seated office cuff systolic blood pressure (mmHg)'}, {'measure': 'Cuff DBP', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Seated office cuff diastolic blood pressure (mmHg)'}, {'measure': 'Ambulatory Brachial Double Product', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': '24-hour mean heart rate x 24-hour mean systolic BP'}, {'measure': 'Ambulatory Mean Heart Rate', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean heart rate over 24 hours'}, {'measure': 'Ambulatory Mean Central Diastolic BP', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory aortic (central) diastolic pressure over 24 hours'}, {'measure': '24-hour Brachial Systolic BP', 'timeFrame': '4 weeks', 'description': 'Mean 24-hour ambulatory systolic BP'}, {'measure': '24-hour Brachial Diastolic BP', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean 24-hour ambulatory cuff diastolic BP'}, {'measure': 'Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Determined by ambulatory heart rate-central systolic pressure product during self-reported waking hours at the end of each study phase'}, {'measure': 'Nighttime ACRPP', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours'}, {'measure': 'Daytime Heart Rate', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory heart rate during self-reported waking hours'}, {'measure': 'Nighttime Heart Rate', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory heart rate during self-reported sleeping hours'}, {'measure': 'Daytime Central Systolic Pressure', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory central systolic pressure during self-reported waking hours'}, {'measure': 'Nighttime Central Systolic Pressure', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory central systolic pressure during self-reported sleeping hours'}, {'measure': 'Daytime Brachial Systolic Pressure', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory brachial systolic pressure during self-reported waking hours'}, {'measure': 'Nighttime Brachial Systolic Pressure', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory brachial systolic pressure during self-reported sleeping hours'}, {'measure': 'Daytime Central Diastolic Pressure', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory central diastolic pressure during self-reported waking hours'}, {'measure': 'Nighttime Central Diastolic Pressure', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory central diastolic pressure during self-reported sleeping hours'}, {'measure': 'Daytime Brachial Diastolic Pressure', 'timeFrame': '4 weeks', 'description': 'Mean ambulatory brachial diastolic pressure during self-reported waking hours'}, {'measure': 'Nighttime Brachial Diastolic Pressure', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory brachial diastolic pressure during self-reported sleeping hours'}, {'measure': 'Ambulatory Daytime Brachial Rate-pressure Product', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours'}, {'measure': 'Ambulatory Nighttime Brachial Rate-pressure Product', 'timeFrame': 'After 4 weeks in each treatment arm', 'description': 'Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial oxygen consumption', 'Systolic blood pressure', 'Diastolic blood pressure', 'Variability in hemodynamic indicators', 'Valsartan', 'Nebivolol', 'IEM ambulatory monitoring'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '26116459', 'type': 'RESULT', 'citation': 'Izzo JL Jr, Khan SU, Saleem O, Osmond PJ. Ambulatory 24-hour cardiac oxygen consumption and blood pressure-heart rate variability: effects of nebivolol and valsartan alone and in combination. J Am Soc Hypertens. 2015 Jul;9(7):526-35. doi: 10.1016/j.jash.2015.03.009. Epub 2015 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'A randomized,double-blind, active controlled,15 week study to evaluate the effects of nebivolol and valsartan alone and in combination on 24-hour ambulatory cardiac work and variability of heart rate-mean central systolic pressure product.', 'detailedDescription': 'Subjects with hypertension (systolic blood pressure (SBP) \\>140 or diastolic blood pressure (DBP)\\>90, n=26) were studied using a double-blinded, forced-titration, sequence-controlled, crossover design with 3 experimental periods: Valsartan 320, nebivolol 40, and nebivolol/valsartan 320/40 mg daily. After 4 weeks of each drug, ambulatory pulse wave analysis (IEM MobilOGraph) was performed every 20 min for 24-hours. The primary hypothesis was that nebivolol/valsartan combination therapy would be superior to valsartan monotherapy in reducing mean 24-hour mean myocardial oxygen consumption determined by 24-hour ambulatory heart rate-central systolic pressure product \\[ACRPP\\]. A secondary hypothesis was that the combination would also reduce the variability of 24-hour myocardial oxygen consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with chronic hypertension, treated or untreated\n\n * Males and females, 18 years or older\n * Seated clinic systolic BP 145-184 mmHg inclusive or\n * Seated clinic diastolic BP 92-119 mmHg, inclusive.\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions will be excluded:\n\n * Any acute or chronic medical condition that, in the judgment of the investigator, renders the subject unable to complete the study, would interfere with optimal participation in the study, or cause significant risk to the subject\n * Concomitant or probable need for treatment with other cardiovascular or antihypertensive drugs that may affect blood pressure or influence the effects of study drugs, (e.g. NSAIDs, beta-agonist inhalers therapy for bronchospastic asthma, diuretics); other stable chronic medications that have little effect on study drugs (e.g. diabetes medications, hormone replacements, chronic pain medications. osteoporosis drugs, vitamins, cholesterol drugs, etc.) are permitted if continued at stable doses throughout study.\n * History of clinically significant adverse events with beta-blocker or angiotensin-receptor blocker\n * Known or suspected secondary hypertension (e.g., renovascular hypertension, primary hyperaldosteronism, etc.)\n * Known ischemic heart disease requiring continuous beta-blocker therapy (includes angina, prior transmural myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty or stenting within 6 months prior to study entry).\n * Dilated cardiomyopathy (NYHA Functional Class III-IV)\n * Clinically significant valvular heart disease or obstructive hypertrophic cardiomyopathy\n * Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter), pre-excitation syndrome, second or third degree atrioventricular block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome.\n * Chronic kidney disease (serum creatinine \\>2.5 mg/dL)\n * Uncontrolled diabetes mellitus (hemoglobin A1c \\> 10%)\n * History of alcohol or other drug abuse within 6 months prior to enrollment\n * Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential'}, 'identificationModule': {'nctId': 'NCT05170061', 'acronym': 'ACRPP', 'briefTitle': '24 Hour Ambulatory Cardiac Oxygen Consumption', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Ambulatory 24-Hour Cardiac Oxygen Consumption and Blood Pressure-Heart Rate Variability: Effects of Nebivolol and Valsartan Alone and in Combination', 'orgStudyIdInfo': {'id': 'BYS-IT-76'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily', 'interventionNames': ['Drug: Nebivolol', 'Drug: Valsartan', 'Drug: Nebivolol/valsartan combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan', 'description': 'Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily', 'interventionNames': ['Drug: Nebivolol', 'Drug: Valsartan', 'Drug: Nebivolol/valsartan combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily;', 'interventionNames': ['Drug: Nebivolol', 'Drug: Valsartan', 'Drug: Nebivolol/valsartan combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,', 'description': 'Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily;', 'interventionNames': ['Drug: Nebivolol', 'Drug: Valsartan', 'Drug: Nebivolol/valsartan combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily;', 'interventionNames': ['Drug: Nebivolol', 'Drug: Valsartan', 'Drug: Nebivolol/valsartan combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,', 'description': 'Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then', 'interventionNames': ['Drug: Nebivolol', 'Drug: Valsartan', 'Drug: Nebivolol/valsartan combination']}], 'interventions': [{'name': 'Nebivolol', 'type': 'DRUG', 'otherNames': ['Bystolic'], 'description': 'Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)', 'armGroupLabels': ['Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan', 'Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan', 'Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,', 'Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,', 'Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,', 'Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,']}, {'name': 'Valsartan', 'type': 'DRUG', 'otherNames': ['Diovan'], 'description': 'Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).', 'armGroupLabels': ['Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan', 'Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan', 'Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,', 'Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,', 'Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,', 'Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,']}, {'name': 'Nebivolol/valsartan combination', 'type': 'DRUG', 'otherNames': ['Diovan/Bystolic'], 'description': 'Valsartan/Nebivolol, 160/20 mg daily (1 week) followed by valsartan/nebivolol 320/40 mg daily (3 weeks) followed by valsartan/nebivolol 160/20 mg daily (1 week)', 'armGroupLabels': ['Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan', 'Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan', 'Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,', 'Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,', 'Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,', 'Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Joseph L Izzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'JOSEPH IZZO', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}