Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-08 @ 11:22 PM
Study NCT ID:
NCT02575833
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2015-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605816', 'term': 'erenumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 6, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Erenumab 140 mg', 'description': 'Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 4, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Exercise Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '14.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.0', 'ciLowerLimit': '-44.9', 'ciUpperLimit': '22.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.4', 'groupDescription': 'The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (\\< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin was -90 seconds.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and day 1, after dosing', 'description': 'Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol.\n\nThe Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received study drug and completed the baseline and post-randomization exercise treadmill tests'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Exercise-induced Angina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}], 'classes': [{'categories': [{'measurements': [{'value': '508.0', 'groupId': 'OG000', 'lowerLimit': '405.0', 'upperLimit': '572.0'}, {'value': '500.0', 'groupId': 'OG001', 'lowerLimit': '420.0', 'upperLimit': '540.0'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal score', 'paramValue': '1.55', 'estimateComment': 'A normal score \\< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Log rank test stratified by baseline total exercise time strata (\\< 7 minutes or ≥ 7 minutes).', 'nonInferiorityComment': 'The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.'}, {'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.11', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.69', 'estimateComment': 'Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by stratified baseline total exercise time strata (\\< 7 or ≥ 7 minutes)'}, {'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.81', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.26', 'estimateComment': 'Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by continuous baseline total exercise time'}, {'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.82', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.28', 'estimateComment': 'Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by baseline total exercise time strata (\\< 7 or ≥ 7 minutes), age group (\\< 65, ≥ 65), and sex.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'Time to onset of angina was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.', 'unitOfMeasure': 'seconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received study drug and completed the post-randomization exercise treadmill test'}, {'type': 'SECONDARY', 'title': 'Time to Onset of ≥ 1 mm ST-segment Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}, {'id': 'OG001', 'title': 'Erenumab', 'description': 'Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}], 'classes': [{'categories': [{'measurements': [{'value': '420.0', 'groupId': 'OG000', 'lowerLimit': '409.0', 'upperLimit': '480.0'}, {'value': '407.0', 'groupId': 'OG001', 'lowerLimit': '380.0', 'upperLimit': '443.0'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal score', 'paramValue': '2.2', 'estimateComment': 'A normal score \\< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Log rank test stratified by baseline total exercise time strata (\\< 7 minutes or ≥ 7 minutes).', 'nonInferiorityComment': 'The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.14', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.69', 'estimateComment': 'Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by stratified baseline total exercise time strata (\\< 7 or ≥ 7 minutes)'}, {'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.08', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.60', 'estimateComment': 'Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by continuous baseline total exercise time'}, {'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.24', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.87', 'estimateComment': 'Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \\< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.', 'statisticalMethod': 'Cox Proportional Hazard', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted by baseline total exercise time strata (\\< 7 or ≥ 7 minutes), age group (\\< 65, ≥ 65), and sex.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'Time to onset of ≥ 1 mm ST-segment depression was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.\n\nHeart rate and rhythm were monitored during the exercise treadmill test by electrocardiography (ECG).', 'unitOfMeasure': 'seconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received study drug and completed the post-randomization exercise treadmill test.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants randomized to receive a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}, {'id': 'FG001', 'title': 'Erenumab', 'description': 'Participants randomized to receive a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 35 centers across the United States, South Africa, New Zealand, and the European Union (EU). Participants were enrolled from November 2015 to January 2017.', 'preAssignmentDetails': 'Participants were randomized in a 1:1 ratio to receive either a single dose of erenumab 140 mg or placebo intravenously (IV) prior to starting an exercise treadmill test. Randomization was stratified by the total exercise time average (\\< 7 minutes or ≥ 7 minutes) of the 2 qualifying exercise treadmill tests performed during screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants randomized to receive a single dose of placebo administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}, {'id': 'BG001', 'title': 'Erenumab', 'description': 'Participants randomized to receive a single dose of erenumab 140 mg administered by intravenous infusion on day 1 prior to starting an exercise treadmill test.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': '18 - < 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '65 - 85 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black (or African American)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Total Exercise Time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '474.8', 'spread': '149.5', 'groupId': 'BG000'}, {'value': '490.7', 'spread': '149.7', 'groupId': 'BG001'}, {'value': '482.7', 'spread': '148.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total exercise time (TET) was assessed using an exercise treadmill test according to the standard Bruce protocol.\n\nThe Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes.', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with non-missing values; baseline TET value was not calculated for two participants in the Erenumab arm due to disqualified screening values.'}, {'title': 'Stratification Factor: Total Exercise Time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 7 minutes', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '≥ 7 minutes', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two participants in the Erenumab arm were incorrectly stratified to the \\< 7 minutes stratum due to disqualified screening TET values.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-13', 'size': 3235773, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-21T14:49', 'hasProtocol': True}, {'date': '2017-04-13', 'size': 731697, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-21T14:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'dispFirstSubmitDate': '2017-11-09', 'completionDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2015-10-07', 'dispFirstSubmitQcDate': '2017-11-09', 'resultsFirstSubmitDate': '2018-05-21', 'studyFirstSubmitQcDate': '2015-10-13', 'dispFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-06', 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Exercise Time', 'timeFrame': 'Baseline and day 1, after dosing', 'description': 'Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol.\n\nThe Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes.'}], 'secondaryOutcomes': [{'measure': 'Time to Onset of Exercise-induced Angina', 'timeFrame': 'Day 1', 'description': 'Time to onset of angina was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.'}, {'measure': 'Time to Onset of ≥ 1 mm ST-segment Depression', 'timeFrame': 'Day 1', 'description': 'Time to onset of ≥ 1 mm ST-segment depression was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.\n\nHeart rate and rhythm were monitored during the exercise treadmill test by electrocardiography (ECG).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Angina', 'Stable Angina', 'Cardiovascular Disease', 'Exercise-induced Angina'], 'conditions': ['Stable Angina']}, 'referencesModule': {'references': [{'pmid': '29878340', 'type': 'BACKGROUND', 'citation': 'Depre C, Antalik L, Starling A, Koren M, Eisele O, Lenz RA, Mikol DD. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Erenumab on Exercise Time During a Treadmill Test in Patients With Stable Angina. Headache. 2018 May;58(5):715-723. doi: 10.1111/head.13316.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise time during an exercise treadmill test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* History of chronic stable angina or at least 3 months prior to screening, with at least 1 angina episode per month\n* Ischemic heart disease documented by myocardial infarction, coronary angiography or a revascularization procedure\n* Receiving stable doses of cardiac medication\n* Completes 2 exercise treadmill tests during screening meeting protocol requirements\n\nExclusion Criteria:\n\n* Participating in another investigational study\n* Current or prior malignancy within 5 years of randomization\n* Known sensitivity to any components of the investigational product\n* Not able to complete all protocol required study visits\n* Having the following within 3 months prior to or during screening: Unstable angina or acute coronary syndrome, transient Ischemic attack (TIA) or stroke, revascularization procedure, or instability in ST-segment depression between screening exercise treadmill tests, as assessed by the core electrocardiograph (ECG) laboratory'}, 'identificationModule': {'nctId': 'NCT02575833', 'briefTitle': 'Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina', 'orgStudyIdInfo': {'id': '20140254'}, 'secondaryIdInfos': [{'id': '2015-002322-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a single dose of placebo administered by intravenous infusion on day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Erenumab', 'description': 'Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.', 'interventionNames': ['Drug: Erenumab']}], 'interventions': [{'name': 'Erenumab', 'type': 'DRUG', 'otherNames': ['AMG 334', 'Aimovig™'], 'description': 'A single dose of erenumab 140 mg infused over approximately 60 minutes.', 'armGroupLabels': ['Erenumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A single dose of a matching volume of placebo infused over approximately 60 minutes.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 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