Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT01044693
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2010-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nebivolol in the Supine Hypertension of Autonomic Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D054970', 'term': 'Pure Autonomic Failure'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D000068577', 'term': 'Nebivolol'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'italo.biaggioni@vanderbilt.edu', 'phone': '615-936-3420', 'title': 'Italo Biaggioni MD', 'organization': 'Vanderbilt University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day for each intervention', 'description': 'Safety population included all participants', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Capsule', 'description': 'Placebo capsule\n\nPlacebo: Placebo capsule', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nebivolol 5 mg', 'description': 'Nebivolol 5 mg capsule\n\nNebivolol 5 mg: Nebivolol 5mg single oral dose', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Metoprolol Tartrate 50 mg', 'description': 'Metoprolol tartrate 50 mg single oral dose\n\nmetoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sildenafil 25 mg', 'description': 'Sildenafil 25 mg single oral dose\n\nSildenafil25 mg: Sildenafil 25 mg single oral dose', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fall', 'notes': 'Participant got up on his own to go to the bathroom during the night, partly falling and injuring his right 5th finger (dislocated).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Urinary Tract Infection and diarrhea', 'notes': 'During study participation, it was found that she had a urinary tract infection (UTI), which contributed to the worsening of hypotension. Subject was taken off the study and treatment for UTI started. She was discharged without further incident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure During the Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Capsule', 'description': 'Placebo capsule\n\nPlacebo: Placebo capsule'}, {'id': 'OG001', 'title': 'Nebivolol 5 mg', 'description': 'Nebivolol 5 mg capsule\n\nNebivolol 5 mg: Nebivolol 5mg single oral dose'}, {'id': 'OG002', 'title': 'Metoprolol Tartrate 50 mg', 'description': 'Metoprolol tartrate 50 mg single oral dose\n\nmetoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose'}, {'id': 'OG003', 'title': 'Sildenafil 25 mg', 'description': 'Sildenafil 25 mg single oral dose\n\nSildenafil25 mg: Sildenafil 25 mg single oral dose'}], 'classes': [{'title': 'Baseline supine at 8 pm', 'categories': [{'measurements': [{'value': '154', 'spread': '7', 'groupId': 'OG000'}, {'value': '162', 'spread': '5', 'groupId': 'OG001'}, {'value': '157', 'spread': '5', 'groupId': 'OG002'}, {'value': '158', 'spread': '6', 'groupId': 'OG003'}]}]}, {'title': 'Change in systolic BP', 'categories': [{'measurements': [{'value': '1', 'spread': '7', 'groupId': 'OG000'}, {'value': '-24', 'spread': '9', 'groupId': 'OG001'}, {'value': '-7', 'spread': '6', 'groupId': 'OG002'}, {'value': '-20', 'spread': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 pm - 8 am', 'description': 'Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 4 treatment arms'}, {'type': 'SECONDARY', 'title': 'Nocturnal Urinary Sodium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Capsule', 'description': 'Placebo capsule\n\nPlacebo: Placebo capsule'}, {'id': 'OG001', 'title': 'Nebivolol 5 mg', 'description': 'Nebivolol 5 mg capsule\n\nNebivolol 5 mg: Nebivolol 5mg single oral dose'}, {'id': 'OG002', 'title': 'Metoprolol Tartrate 50 mg', 'description': 'Metoprolol tartrate 50 mg single oral dose\n\nmetoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose'}, {'id': 'OG003', 'title': 'Sildenafil 25 mg', 'description': 'Sildenafil 25 mg single oral dose\n\nSildenafil25 mg: Sildenafil 25 mg single oral dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.145', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.127', 'spread': '0.011', 'groupId': 'OG001'}, {'value': '0.139', 'spread': '0.019', 'groupId': 'OG002'}, {'value': '0.125', 'spread': '0.018', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.607', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The main comparisons were between the active treatment groups versus placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 pm - 8 am', 'description': 'Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.', 'unitOfMeasure': 'mEq/mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with complete urine collections during the 4 study nights'}, {'type': 'SECONDARY', 'title': 'Orthostatic Tolerance the Following Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Capsule', 'description': 'Placebo capsule\n\nPlacebo: Placebo capsule'}, {'id': 'OG001', 'title': 'Nebivolol 5 mg', 'description': 'Nebivolol 5 mg capsule\n\nNebivolol 5 mg: Nebivolol 5mg single oral dose'}, {'id': 'OG002', 'title': 'Metoprolol Tartrate 50 mg', 'description': 'Metoprolol tartrate 50 mg single oral dose\n\nmetoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose'}, {'id': 'OG003', 'title': 'Sildenafil 25 mg', 'description': 'Sildenafil 25 mg single oral dose\n\nSildenafil25 mg: Sildenafil 25 mg single oral dose'}], 'classes': [{'categories': [{'measurements': [{'value': '594', 'spread': '108', 'groupId': 'OG000'}, {'value': '675', 'spread': '113', 'groupId': 'OG001'}, {'value': '696', 'spread': '128', 'groupId': 'OG002'}, {'value': '575', 'spread': '106', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.597', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The main comparisons were between the active treatment groups versus placebo.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 min standing', 'description': 'Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test', 'unitOfMeasure': 'mm Hg*min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons were made only for patients who could stand after all treatment groups'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate During the Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Capsule', 'description': 'Placebo capsule\n\nPlacebo: Placebo capsule'}, {'id': 'OG001', 'title': 'Nebivolol 5 mg', 'description': 'Nebivolol 5 mg capsule\n\nNebivolol 5 mg: Nebivolol 5mg single oral dose'}, {'id': 'OG002', 'title': 'Metoprolol Tartrate 50 mg', 'description': 'Metoprolol tartrate 50 mg single oral dose\n\nmetoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose'}, {'id': 'OG003', 'title': 'Sildenafil 25 mg', 'description': 'Sildenafil 25 mg single oral dose\n\nSildenafil25 mg: Sildenafil 25 mg single oral dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '2', 'groupId': 'OG000'}, {'value': '-6', 'spread': '2', 'groupId': 'OG001'}, {'value': '-6', 'spread': '2', 'groupId': 'OG002'}, {'value': '0', 'spread': '2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.996', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 pm - 8 am', 'description': 'Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 4 treatment arms'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Then Metoprolol Then Sildenafil Then Nebivolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG001', 'title': 'Placebo Then Nebivolol Then Metoprolol Then Sildenafil', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG002', 'title': 'Placebo Then Sildenafil Then Nebivolol Then Metoprolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG003', 'title': 'Placebo Then Sildenafil Then Metoprolol Then Nebivolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG004', 'title': 'Nebivolol Then Placebo Then Metoprolol Then Sildenafil', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG005', 'title': 'Metoprolol Then Sildenafil Then Placebo Then Nebivolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG006', 'title': 'Sildenafil Then Nebivolol Then Placebo Then Metoprolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG007', 'title': 'Metoprolol Then Placebo Then Nebivolol Then Sildenafil', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG008', 'title': 'Nebivolol Then Metoprolol Then Sildenafil Then Placebo', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG009', 'title': 'Metoprolol Then Nebivolol Then Placebo Then Sildenafil', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG010', 'title': 'Metoprolol Then Sildenafil Then Nebivolol Then Placebo', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG011', 'title': 'Sildenafil Then Nebivolol Then Metoprolol Then Placebo', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG012', 'title': 'Sildenafil Then Metoprolol Then Nebivolol Then Placebo', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG013', 'title': 'Nebivolol Then Sildenafil Then Metoprolol Then Placebo', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG014', 'title': 'Nebivolol Then Placebo Then Sildenafil Then Metoprolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}, {'id': 'FG015', 'title': 'Placebo Then Nebivolol Then Sildenafil Then Metoprolol', 'description': 'Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '1'}]}, {'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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '3.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of disease', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnosis', 'classes': [{'title': 'Pure autonomic failure', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Parkinson Disease with autonomic failure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Multiple System Atrophy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medical history of essential hypertension', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Systolic BP, supine', 'classes': [{'categories': [{'measurements': [{'value': '169', 'spread': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic BP, upright', 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate, supine', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate, upright', 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plasma norepinephrine, supine', 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plasma norepinephrine, upright', 'classes': [{'categories': [{'measurements': [{'value': '253', 'spread': '209', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients with primary forms of autonomic failure and supine hypertension'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2010-01-06', 'resultsFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-14', 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure During the Night', 'timeFrame': '8 pm - 8 am', 'description': 'Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention'}], 'secondaryOutcomes': [{'measure': 'Nocturnal Urinary Sodium Excretion', 'timeFrame': '8 pm - 8 am', 'description': 'Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.'}, {'measure': 'Orthostatic Tolerance the Following Morning', 'timeFrame': '10 min standing', 'description': 'Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test'}, {'measure': 'Change in Heart Rate During the Night', 'timeFrame': '8 pm - 8 am', 'description': 'Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['supine Hypertension', 'autonomic failure', 'nitric oxide', 'nebivolol'], 'conditions': ['Hypertension', 'Pure Autonomic Failure', 'Multiple System Atrophy']}, 'referencesModule': {'references': [{'pmid': '7680352', 'type': 'BACKGROUND', 'citation': 'Biaggioni I, Garcia F, Inagami T, Haile V. Hyporeninemic normoaldosteronism in severe autonomic failure. J Clin Endocrinol Metab. 1993 Mar;76(3):580-6. doi: 10.1210/jcem.76.3.7680352.'}, {'pmid': '7562470', 'type': 'BACKGROUND', 'citation': 'Cockcroft JR, Chowienczyk PJ, Brett SE, Chen CP, Dupont AG, Van Nueten L, Wooding SJ, Ritter JM. Nebivolol vasodilates human forearm vasculature: evidence for an L-arginine/NO-dependent mechanism. J Pharmacol Exp Ther. 1995 Sep;274(3):1067-71.'}, {'pmid': '18426998', 'type': 'BACKGROUND', 'citation': 'Gamboa A, Shibao C, Diedrich A, Paranjape SY, Farley G, Christman B, Raj SR, Robertson D, Biaggioni I. Excessive nitric oxide function and blood pressure regulation in patients with autonomic failure. Hypertension. 2008 Jun;51(6):1531-6. doi: 10.1161/HYPERTENSIONAHA.107.105171. Epub 2008 Apr 21.'}, {'pmid': '18786089', 'type': 'BACKGROUND', 'citation': 'Gupta S, Wright HM. Nebivolol: a highly selective beta1-adrenergic receptor blocker that causes vasodilation by increasing nitric oxide. Cardiovasc Ther. 2008 Fall;26(3):189-202. doi: 10.1111/j.1755-5922.2008.00054.x.'}, {'pmid': '9369256', 'type': 'BACKGROUND', 'citation': 'Shannon J, Jordan J, Costa F, Robertson RM, Biaggioni I. The hypertension of autonomic failure and its treatment. Hypertension. 1997 Nov;30(5):1062-7. doi: 10.1161/01.hyp.30.5.1062.'}, {'pmid': '11479245', 'type': 'BACKGROUND', 'citation': 'Tzemos N, Lim PO, MacDonald TM. Nebivolol reverses endothelial dysfunction in essential hypertension: a randomized, double-blind, crossover study. Circulation. 2001 Jul 31;104(5):511-4. doi: 10.1161/hc3001.094207.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in patients with autonomic failure and supine hypertension.', 'detailedDescription': 'Nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (NO) bioactivity. The contribution of this effect to the pharmacological actions of the drug, however, is difficult to ascertain in normal subjects because of the confounding contribution of the autonomic nervous system. Autonomic failure patients provide a unique model of hypertension devoid of autonomic modulation but sensitive to NO mechanisms. We propose to determine the effect of nebivolol on blood pressure in this patient population. A decrease in blood pressure will imply increased bioactivity of NO. Comparisons will be made with placebo, metoprolol (as a negative control) and sildenafil (as a positive control).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female and aged 18 years or over.\n* Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).\n* A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.\n* Supine hypertension, defined as a systolic blood pressure \\>150 mm Hg or diastolic blood pressure \\> 90 mm Hg.\n* Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.\n\nExclusion Criteria:\n\n* Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.\n* Women of childbearing potential who are not using a medically accepted contraception.\n* Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.\n* Diabetes mellitus or insipidus.\n* In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.\n* In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.\n* In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.\n* Are not able or willing to comply with the study requirements for the duration of the study.\n* Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin)."}, 'identificationModule': {'nctId': 'NCT01044693', 'briefTitle': 'Nebivolol in the Supine Hypertension of Autonomic Failure', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Effect of Nebivolol on Blood Pressure in a Model of Hypertension Sensitive to Potentiation of Nitric Oxide Bioactivity', 'orgStudyIdInfo': {'id': '091252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsule', 'description': 'Placebo capsule', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Nebivolol 5 mg', 'description': 'Nebivolol 5 mg capsule', 'interventionNames': ['Drug: Nebivolol 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoprolol tartrate 50 mg', 'description': 'Metoprolol tartrate 50 mg single oral dose', 'interventionNames': ['Drug: metoprolol tartrate 50 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sildenafil 25 mg', 'description': 'Sildenafil 25 mg single oral dose', 'interventionNames': ['Drug: Sildenafil25 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'Placebo capsule', 'armGroupLabels': ['Placebo capsule']}, {'name': 'Nebivolol 5 mg', 'type': 'DRUG', 'otherNames': ['Bystolic'], 'description': 'Nebivolol 5mg single oral dose', 'armGroupLabels': ['Nebivolol 5 mg']}, {'name': 'metoprolol tartrate 50 mg', 'type': 'DRUG', 'otherNames': ['Lopressor'], 'description': 'metoprolol tartrate 50 mg single oral dose', 'armGroupLabels': ['Metoprolol tartrate 50 mg']}, {'name': 'Sildenafil25 mg', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': 'Sildenafil 25 mg single oral dose', 'armGroupLabels': ['Sildenafil 25 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Italo Biaggioni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Pharmacology', 'investigatorFullName': 'Italo Biaggioni', 'investigatorAffiliation': 'Vanderbilt University'}}}}