Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 6:21 PM
Study NCT ID:
NCT01130168
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2010-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse event data were unavailable for 4 participants in the Placebo treatment group and for 1 participant in the Amlodipine treatment group due to discontinuations during Period 1.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.', 'otherNumAtRisk': 34, 'otherNumAffected': 7, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ISMN ER', 'description': 'Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.', 'otherNumAtRisk': 38, 'otherNumAffected': 18, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.', 'otherNumAtRisk': 37, 'otherNumAffected': 9, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.1', 'spread': '4.5', 'groupId': 'OG000', 'lowerLimit': '-22.0', 'upperLimit': '4.0'}, {'value': '-0.7', 'spread': '4.5', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '8.0'}, {'value': '2.1', 'spread': '4.5', 'groupId': 'OG002', 'lowerLimit': '-6.0', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-15.3', 'ciUpperLimit': '-10.9', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '-0.6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:\n\nHR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.\n\nUnreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose AIx analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '6.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.407', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '4.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '-2.9', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:\n\nHR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.\n\nUnreliable SphygmoCor® data were collected for two participants in the ISM ER treatment group, therefore these participants were excluded from the multiple dose AIx analysis.'}, {'type': 'PRIMARY', 'title': 'TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '7.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.4', 'ciLowerLimit': '-21.2', 'ciUpperLimit': '-10.1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-17.4', 'ciUpperLimit': '-6.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.\n\nUnreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose SBP analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '11.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.186', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '1.8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.1', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '-10.5', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.\n\nUnreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose SBP analysis.'}, {'type': 'PRIMARY', 'title': 'TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '5.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-12.1', 'ciUpperLimit': '-6.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '-0.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.\n\nUnreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose DBP analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '9.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.428', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '2.6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-13.1', 'ciUpperLimit': '-4.5', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.\n\nUnreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose DBP analysis.'}, {'type': 'PRIMARY', 'title': 'TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.1', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '7.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '-10.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '-1.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-20.7', 'ciUpperLimit': '-9.8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.'}, {'type': 'PRIMARY', 'title': 'TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.0', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '-6.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ISMN ER', 'description': 'ISMN ER was administered as a 30 mg single daily dose over 4 weeks.'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine was administered as a 10 mg single daily dose over 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered as a single once daily dose during 4 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '8.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.267', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '1.8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '-4.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.', 'unitOfMeasure': 'mm mercury (Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/ISMN ER/Amlodipine (Sequence 1)', 'description': 'Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. Experimental: ISMN ER/Amlodipine/Placebo'}, {'id': 'FG001', 'title': 'ISMN ER/Amlodipine/Placebo (Sequence 2)', 'description': 'Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period'}, {'id': 'FG002', 'title': 'Amlodipine/Placebo/ISMN ER (Sequence 3)', 'description': 'Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period'}, {'id': 'FG003', 'title': 'ISMN ER/Placebo/Amlodipine (Sequence 4)', 'description': 'Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.'}, {'id': 'FG004', 'title': 'Placebo/Amlodipine/ISMN ER (Sequence 5)', 'description': 'Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.'}, {'id': 'FG005', 'title': 'Amlodipine/ISMN ER/Placebo (Sequence 6)', 'description': 'Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Discontinued For Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'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'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '7.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age data were not reported for 5 participants who were excluded from analysis.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender data were not reported for 5 participants who were excluded from analysis.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2010-05-19', 'resultsFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-26', 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:\n\nHR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses.'}, {'measure': 'Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:\n\nHR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses.'}, {'measure': 'TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.'}, {'measure': 'Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.'}, {'measure': 'TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.'}, {'measure': 'Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.'}, {'measure': 'TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.'}, {'measure': 'Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.'}, {'measure': 'TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment', 'timeFrame': 'Baseline (0 hrs), 12 hours post-dose (Day 1)', 'description': 'Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.'}, {'measure': 'Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment', 'timeFrame': 'Baseline (0 hrs), 24 hours after the Day 28 dose', 'description': 'Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is a male or female between 30 and 65 years of age (inclusive) at the pre-study (screening)\n* Female participant of childbearing potential must have a negative pregnancy test\n* Participant has a brachial systolic blood pressure \\>130 mm Hg\n\nand \\<180 mm Hg\n\n* Participant has a Body Mass Index (BMI) that is \\>20 kg/m\\^2 and \\<35 kg/m\\^2\n* Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months\n\nExclusion Criteria:\n\n* Female Participant is pregnant or lactating\n* Participant anticipates the use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) other than acetaminophen\n* Participant is currently a user (including "recreational use") of any illicit drugs, has a history of drug or alcohol abuse within approximately 2 years, or has a positive prestudy urine drug screen\n* Participant has a condition for which there is a warning, contraindication, or precaution against the use of ISMN ER including: acute myocardial infarction or congestive heart failure, hypotension, volume depletion, and pregnancy\n* Participant has a history of significant drug allergy or any clinically significant adverse experience of a serious nature related to the administration of either a marketed or an investigational drug, including nitrates, nitrites, Amlodipine, and ISMN ER'}, 'identificationModule': {'nctId': 'NCT01130168', 'briefTitle': 'The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Evaluate the Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Subjects and Patients With Hypertension', 'orgStudyIdInfo': {'id': '0000-166'}, 'secondaryIdInfos': [{'id': '2010_537'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo/ISMN ER/Amlodipine (Sequence 1)', 'description': 'Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Comparator: Amlodipine', 'Drug: Comparator: ISMN ER']}, {'type': 'EXPERIMENTAL', 'label': 'ISMN ER/Amlodipine/Placebo (Sequence 2)', 'description': 'Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Comparator: Amlodipine', 'Drug: Comparator: ISMN ER']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine/Placebo/ISMN ER (Sequence 3)', 'description': 'Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Comparator: Amlodipine', 'Drug: Comparator: ISMN ER']}, {'type': 'EXPERIMENTAL', 'label': 'ISMN ER/Placebo/Amlodipine (Sequence 4)', 'description': 'Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Comparator: Amlodipine', 'Drug: Comparator: ISMN ER']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/Amlodipine/ISMN ER (Sequence 5)', 'description': 'Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Comparator: Amlodipine', 'Drug: Comparator: ISMN ER']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine/ISMN ER/Placebo (Sequence 6)', 'description': 'Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.', 'interventionNames': ['Drug: Placebo', 'Drug: Comparator: Amlodipine', 'Drug: Comparator: ISMN ER']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, capsule taken orally once daily during 4 weeks of treatment', 'armGroupLabels': ['Amlodipine/ISMN ER/Placebo (Sequence 6)', 'Amlodipine/Placebo/ISMN ER (Sequence 3)', 'ISMN ER/Amlodipine/Placebo (Sequence 2)', 'ISMN ER/Placebo/Amlodipine (Sequence 4)', 'Placebo/Amlodipine/ISMN ER (Sequence 5)', 'Placebo/ISMN ER/Amlodipine (Sequence 1)']}, {'name': 'Comparator: Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks', 'armGroupLabels': ['Amlodipine/ISMN ER/Placebo (Sequence 6)', 'Amlodipine/Placebo/ISMN ER (Sequence 3)', 'ISMN ER/Amlodipine/Placebo (Sequence 2)', 'ISMN ER/Placebo/Amlodipine (Sequence 4)', 'Placebo/Amlodipine/ISMN ER (Sequence 5)', 'Placebo/ISMN ER/Amlodipine (Sequence 1)']}, {'name': 'Comparator: ISMN ER', 'type': 'DRUG', 'description': 'ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks', 'armGroupLabels': ['Amlodipine/ISMN ER/Placebo (Sequence 6)', 'Amlodipine/Placebo/ISMN ER (Sequence 3)', 'ISMN ER/Amlodipine/Placebo (Sequence 2)', 'ISMN ER/Placebo/Amlodipine (Sequence 4)', 'Placebo/Amlodipine/ISMN ER (Sequence 5)', 'Placebo/ISMN ER/Amlodipine (Sequence 1)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}