Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT00396656
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2006-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
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': 'D001262', 'term': 'Atenolol'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': {'phone': '862 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Two patients in the treatment sequence atenolol + hydrochlorothiazide followed by valsartan did not receive treatment during the second treatment period and were excluded from the valsartan safety population analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.', 'otherNumAtRisk': 28, 'otherNumAffected': 16, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.', 'otherNumAtRisk': 30, 'otherNumAffected': 12, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.'}, {'id': 'OG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.21', 'spread': '38.11', 'groupId': 'OG000'}, {'value': '61.04', 'spread': '49.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.', 'unitOfMeasure': 'Perfusion units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.'}, {'id': 'OG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.11', 'spread': '22.19', 'groupId': 'OG000'}, {'value': '-5.60', 'spread': '40.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.', 'unitOfMeasure': 'Perfusion units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.'}, {'id': 'OG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '120.65', 'spread': '74.52', 'groupId': 'OG000'}, {'value': '128.14', 'spread': '63.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.', 'unitOfMeasure': 'Perfusion units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Mean Post-treatment Microcirculation at NaCl Injected Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.'}, {'id': 'OG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.78', 'spread': '47.53', 'groupId': 'OG000'}, {'value': '50.96', 'spread': '67.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.', 'unitOfMeasure': 'Perfusion units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Arterial Pressure Waveform Augmentation Index at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.'}, {'id': 'OG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '139.05', 'spread': '20.64', 'groupId': 'OG000'}, {'value': '144.51', 'spread': '21.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': 'Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valsartan', 'description': 'Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.'}, {'id': 'OG001', 'title': 'Atenolol + Hydrochlorothiazide', 'description': 'Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.07', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '7.60', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': 'Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)', 'description': 'After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.\n\nAfter a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.'}, {'id': 'FG001', 'title': 'Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan', 'description': 'After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.\n\nAfter a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning'}], 'periods': [{'title': 'First Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-05', 'studyFirstSubmitDate': '2006-11-06', 'resultsFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2006-11-06', 'lastUpdatePostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-05', 'studyFirstPostDateStruct': {'date': '2006-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.'}], 'secondaryOutcomes': [{'measure': 'Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.'}, {'measure': 'Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.'}, {'measure': 'Mean Post-treatment Microcirculation at NaCl Injected Sites', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': '10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.'}, {'measure': 'Arterial Pressure Waveform Augmentation Index at the End of Treatment', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': 'Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.'}, {'measure': 'Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment', 'timeFrame': 'At end of each treatment period (Week 21 and Week 43)', 'description': 'Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.'}]}, 'conditionsModule': {'keywords': ['hypertension', 'valsartan', 'atenolol', 'hydrochlorothiazide', 'microcirculation', 'arterial compliance', 'pulse wave analysis'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.\n* At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and \\< 110 mmHg.\n\nExclusion Criteria:\n\n* If a single reading for arterial hypertension in msSBP \\> 180 mmHg or msDBP \\> 110 mmHg at any visit after randomization.\n* Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.\n* Known history of hypotensive symptoms or orthostatic hypotension.\n* Concomitant use of statins or statin intake during the four weeks prior to Visit 1.\n* Known Keith-Wagener grade III or IV hypertensive retinopathy.\n* A history of heart failure (NYHA II-IV).'}, 'identificationModule': {'nctId': 'NCT00396656', 'briefTitle': 'Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Open-label, Multicenter, Cross-over Trial to Evaluate the Efficacy of a 20 Week Treatment of Valsartan 320 mg Versus Atenolol 100 mg in Combination With Hydrochlorothiazide on Microcirculation in Hypertensive Patients', 'orgStudyIdInfo': {'id': 'CVAH631BDE06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)', 'description': 'After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.\n\nAfter a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.', 'interventionNames': ['Drug: Atenolol', 'Drug: Hydrochlorothiazide (HCTZ))', 'Drug: Valsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan', 'description': 'After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.\n\nAfter a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.', 'interventionNames': ['Drug: Atenolol', 'Drug: Hydrochlorothiazide (HCTZ))', 'Drug: Valsartan']}], 'interventions': [{'name': 'Atenolol', 'type': 'DRUG', 'description': '100 mg tablets orally once a day (od) in the morning.', 'armGroupLabels': ['Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan', 'Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)']}, {'name': 'Hydrochlorothiazide (HCTZ))', 'type': 'DRUG', 'description': '12.5 or 25 mg tablets orally once a day (od) in the morning.', 'armGroupLabels': ['Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan', 'Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': '80 mg, 160 mg, or 320 mg tablets orally once a day in the morning', 'armGroupLabels': ['Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan', 'Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Investigative Centers', 'country': 'Germany'}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Pharma Ag', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharma Ag', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anna Mitchell, MD', 'oldOrganization': 'University Hospital Essen, Essen, Germany et al.'}}}}