Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-29 @ 2:19 AM
Study NCT ID:
NCT00799604
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2008-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
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': 'C118563', 'term': 'clevidipine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jason.campagna@themedco.com', 'phone': '973-290-6199', 'title': 'Jason Campagna. MD, PhD', 'organization': 'The Medicines Company'}, 'certainAgreement': {'otherDetails': 'The site agrees that publication of Study results at the site is not permitted until after the presentation and publication of the multi-center results or an affirmative decision is made by Sponsor not to proceed with such publication. In such a case, Sponsor shall provide access to all Study site data to the academic Study Coordination Center, or upon request Sponsor will provide access to all Study site data to Institution. The site will adhere to terms for Sponsor review prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Non-serious AE(s) were documented and assessed following initiation of clevidipine administration through 6 hours post final bolus dose. SAEs were assessed up to 24 hours post final bolus dose, regardless of causal relationship to the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants Across All Cohorts and Treatment Periods', 'description': 'Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.', 'otherNumAtRisk': 30, 'otherNumAffected': 12, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}], 'seriousEvents': [{'term': 'Encephalopathy', 'notes': 'unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.8', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '-37.0', 'spread': '17.76', 'groupId': 'OG001'}, {'value': '-15.8', 'spread': '11.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).', 'description': "Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value.", 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).', 'description': 'The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100.', 'unitOfMeasure': 'percent patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.'}, {'type': 'SECONDARY', 'title': 'The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'title': '5 % Reduction', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.4'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.3'}, {'value': '1.0', 'comment': 'Not Estimable: Unable to be determined due to a lack of enough participants achieving a 5% systolic blood pressure reduction within 15 minutes within this cohort.', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': 'NA'}]}]}, {'title': '10% Reduction', 'categories': [{'measurements': [{'value': '1.3', 'comment': 'Not Estimable: Unable to be determined due to a lack of enough participants achieving a 10% systolic blood pressure reduction within 15 minutes within this cohort.', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': 'NA'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.3'}, {'value': 'NA', 'comment': 'Not Estimable: Unable to be determined due to a lack of enough participants achieving a 10% systolic blood pressure reduction within 15 minutes within this cohort.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '15% Reduction', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Estimable: Unable to be determined due to a lack of enough participants achieving a 15% systolic blood pressure reduction within 15 minutes within this cohort.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.2', 'comment': 'Not Estimable: Unable to be determined due to a lack of enough participants achieving a 15% systolic blood pressure reduction within 15 minutes within this cohort.', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not Estimable: Unable to be determined due to a lack of enough participants achieving a 15% systolic blood pressure reduction within 15 minutes within this cohort.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).', 'description': 'BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.'}, {'type': 'SECONDARY', 'title': 'The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'title': 'SBP 0.25 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '0.96', 'spread': '4.346', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '7.585', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '3.034', 'groupId': 'OG002'}]}]}, {'title': 'SBP 0.5 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '2.79', 'spread': '5.397', 'groupId': 'OG000'}, {'value': '-2.41', 'spread': '6.057', 'groupId': 'OG001'}, {'value': '-1.59', 'spread': '3.172', 'groupId': 'OG002'}]}]}, {'title': 'SBP 0.75 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '-5.22', 'spread': '4.916', 'groupId': 'OG000'}, {'value': '-9.09', 'spread': '6.901', 'groupId': 'OG001'}, {'value': '-5.87', 'spread': '3.705', 'groupId': 'OG002'}]}]}, {'title': 'SBP 1 minute after Bolus 1', 'categories': [{'measurements': [{'value': '-8.37', 'spread': '4.181', 'groupId': 'OG000'}, {'value': '-12.29', 'spread': '8.714', 'groupId': 'OG001'}, {'value': '-5.67', 'spread': '5.848', 'groupId': 'OG002'}]}]}, {'title': 'SBP 1.5 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '-8.64', 'spread': '3.031', 'groupId': 'OG000'}, {'value': '-19.40', 'spread': '8.744', 'groupId': 'OG001'}, {'value': '-6.68', 'spread': '3.694', 'groupId': 'OG002'}]}]}, {'title': 'SBP 2 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '-9.51', 'spread': '4.669', 'groupId': 'OG000'}, {'value': '-20.36', 'spread': '10.773', 'groupId': 'OG001'}, {'value': '-7.07', 'spread': '5.336', 'groupId': 'OG002'}]}]}, {'title': 'SBP 3 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '-6.58', 'spread': '5.492', 'groupId': 'OG000'}, {'value': '-17.95', 'spread': '9.732', 'groupId': 'OG001'}, {'value': '-6.79', 'spread': '5.665', 'groupId': 'OG002'}]}]}, {'title': 'SBP 5 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '-4.23', 'spread': '4.506', 'groupId': 'OG000'}, {'value': '-11.08', 'spread': '5.711', 'groupId': 'OG001'}, {'value': '-3.07', 'spread': '4.170', 'groupId': 'OG002'}]}]}, {'title': 'SBP 7 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '4.909', 'groupId': 'OG000'}, {'value': '-6.77', 'spread': '7.837', 'groupId': 'OG001'}, {'value': '-3.17', 'spread': '3.443', 'groupId': 'OG002'}]}]}, {'title': 'SBP 15 minutes after Bolus 1', 'categories': [{'measurements': [{'value': '0.58', 'spread': '6.119', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '14.384', 'groupId': 'OG001'}, {'value': '-2.32', 'spread': '3.347', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).', 'description': 'BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.'}, {'type': 'SECONDARY', 'title': 'The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL Sol)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'title': 'Time to 50% recovery in SBP', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.9'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.4'}, {'value': '2.5', 'comment': 'Not Estimable: Not reached since \\>50% of patients did not achieve 50% of recovery within 15 min.', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': 'NA'}]}]}, {'title': 'Time to 90% recovery in SBP', 'categories': [{'measurements': [{'value': '5.2', 'comment': 'Not Estimable: Not reached since \\>50% of patients did not achieve 90% of recovery within 15 min.', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': 'NA'}, {'value': '6.8', 'comment': 'Not Estimable: Not reached since \\>50% of patients did not achieve 90% of recovery within 15 min.', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not Estimable: Not reached since \\>50% of patients did not achieve 90% of recovery within 15 min.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia).', 'description': 'Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change).', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate After Bolus 1 (Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '10.15', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia).', 'description': 'The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all enrolled patients (irrespective of eligibility) who are dosed with clevidipine. The safety population will be the primary population used for the safety analyses.'}, {'type': 'PRIMARY', 'title': 'The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'OG002', 'title': 'Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.89', 'spread': '3.851', 'groupId': 'OG000'}, {'value': '-22.10', 'spread': '9.288', 'groupId': 'OG001'}, {'value': '-8.91', 'spread': '5.966', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).', 'description': "Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Planned Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (\\<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Five participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 and one participant who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 250 μg during Treatment Period 2 in this cohort.'}, {'id': 'FG001', 'title': 'Planned Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (\\<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Six participants who received a Bolus 1 dose of 500 μg and six participants who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 500 μg during Treatment Period 2 in this cohort.'}, {'id': 'FG002', 'title': 'Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol)', 'description': 'Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (\\<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Three participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 received a Bolus 2 dose of 125 μg during Treatment Period 2 in this cohort.'}], 'periods': [{'title': 'Bolus 1 (Pre-anesthesia)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Bolus 2 (With Anesthesia)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Dose determined per discretion of investigator at 250, 500 or 125μg, based on response to Bolus 1.', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'Dose determined per discretion of investigator at 250, 500 or 125μg, based on response to Bolus 1.', 'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'Dose determined per discretion of investigator at 250, 500 or 125μg, based on response to Bolus 1.', 'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Thirty patients were enrolled at two hospitals. All received an initial dose of clevidipine (Bolus 1-pre-anesthesia) during Treatment Period 1; 21 participants received a second bolus dose (Bolus 2-with anesthesia)during Treatment 2 per the discretion of the investigator at 250, 500 or 125μg, depending on patient response to Bolus 1.', 'preAssignmentDetails': 'A screening period began up to 14 days prior to study drug administration, consisting of obtaining informed consent, confirming patient eligibility, and collecting screening assessments. Patient eligibility was further verified on treatment day to confirm SPB ≥140 mm Hg prior to study drug. If SBP was \\<140 mm Hg, no study drug was administered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Clevidipine 250 μg (0.5 mL)', 'description': 'Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'BG001', 'title': 'Cohort 2: Clevidipine 500 μg (1.0 mL)', 'description': 'Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which Clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'BG002', 'title': 'Cohort 3: Clevidipine 125 μg ( mL)', 'description': 'Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (\\<5 seconds).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '11.88', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '8.62', 'groupId': 'BG001'}, {'value': '60.2', 'spread': '8.85', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '9.98', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'These results represent Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '0', 'spread': '0', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '0', 'spread': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'spread': '100.0', 'groupId': 'BG000'}, {'value': '10', 'spread': '100.0', 'groupId': 'BG001'}, {'value': '10', 'spread': '100.0', 'groupId': 'BG002'}, {'value': '30', 'spread': '100.0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '0', 'spread': '0', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '0', 'spread': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'These results represent participant groupings during Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'These results represent patient groupings during Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '174.96', 'spread': '10.381', 'groupId': 'BG000'}, {'value': '168.15', 'spread': '11.462', 'groupId': 'BG001'}, {'value': '176.35', 'spread': '9.663', 'groupId': 'BG002'}, {'value': '173.15', 'spread': '10.792', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'These results represent the participant groupings during Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.65', 'spread': '15.374', 'groupId': 'BG000'}, {'value': '79.24', 'spread': '12.639', 'groupId': 'BG001'}, {'value': '105.05', 'spread': '24.724', 'groupId': 'BG002'}, {'value': '88.65', 'spread': '21.279', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'These results represent the participant groupings during Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Screening Blood Pressure', 'classes': [{'title': 'Systolic Blood Pressure (SBP)', 'categories': [{'measurements': [{'value': '159.0', 'spread': '17.45', 'groupId': 'BG000'}, {'value': '170.2', 'spread': '16.33', 'groupId': 'BG001'}, {'value': '175.5', 'spread': '19.43', 'groupId': 'BG002'}, {'value': '168.2', 'spread': '18.53', 'groupId': 'BG003'}]}]}, {'title': 'Diastolic Blood Pressure (DBP)', 'categories': [{'measurements': [{'value': '80.0', 'spread': '8.71', 'groupId': 'BG000'}, {'value': '74.1', 'spread': '10.29', 'groupId': 'BG001'}, {'value': '77.7', 'spread': '11.51', 'groupId': 'BG002'}, {'value': '77.3', 'spread': '10.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'These results represent the participant groupings in Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Screening Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '18.69', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '10.42', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '10.49', 'groupId': 'BG002'}, {'value': '70.3', 'spread': '13.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'These results represent the participant groupings during Treatment Period 1 (Bolus 1 - pre-anesthesia).', 'unitOfMeasure': 'Beats Per Minute (BPM)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'These analyses include the Safety population defined as all participants, irrespective of eligibility, who were enrolled in Treatment Period 1 (Bolus 1 - pre-anesthesia) and were dosed with clevidipine. The number of participants in the Safety population and Modified Intent-To-Treat (mITT) population are identical.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2008-11-26', 'resultsFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2008-11-28', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-12', 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'timeFrame': 'From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).', 'description': "Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value."}, {'measure': 'The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'timeFrame': 'From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).', 'description': "Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100."}], 'secondaryOutcomes': [{'measure': 'The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'timeFrame': 'From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).', 'description': 'The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100.'}, {'measure': 'The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia).', 'timeFrame': 'From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).', 'description': 'BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored.'}, {'measure': 'The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'timeFrame': 'From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).', 'description': 'BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient.'}, {'measure': 'The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia).', 'timeFrame': 'Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia).', 'description': 'Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change).'}, {'measure': 'Change in Heart Rate After Bolus 1 (Pre-anesthesia).', 'timeFrame': 'Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia).', 'description': 'The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Antihypertensive Agent', 'Calcium Channel Blocker'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.', 'detailedDescription': "Study participants were screened up to 14 days prior to their elective cardiac surgery. For the purpose of this study, hypertension was defined as systolic blood pressure (SBP) ≥140 mm Hg immediately prior to initiation of study drug.\n\nOn the day of surgery, an IV bolus dose of clevidipine (Bolus 1 - pre-anesthesia) was administered to each eligible study participant during Treatment Period 1 to decrease BP before induction of general anesthesia. The dose (either 125 μg, 250 μg or 500 μg) given was based on the assigned cohort for each participant, listed in the 'Arms' section below.\n\nAt the discretion of the investigator, a second IV bolus dose of clevidipine (Bolus 2 - with anesthesia) could have been administered during Treatment Period 2 at either 125 μg, 250 μg or 500 μg, based upon the earlier observed response to Bolus 1. This dose was administered after the induction of anesthesia, to decrease BP prior to cannulation of the ascending aorta for initiation of cardiopulmonary bypass.\n\nAssessment of safety was performed throughout Treatment Periods 1 and 2 with Adverse Events (AEs) followed 6 hours post final bolus dose and Serious Adverse Events (SAEs) followed 24 hours post final bolus dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Require elective cardiac operation involving the use of cardiopulmonary bypass\n* Age 18 years or older\n* A history or hypertension and/or expected to require perioperative antihypertensive therapy in the opinion of the investigator\n* Written informed consent\n* Pre-anesthesia baseline SBP ≥140 mm Hg just prior to bolus, measured using an arterial line\n\nExclusion Criteria:\n\n* Receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72 hours prior to dosing\n* Critical left main coronary artery stenosis\n* Critical aortic valve (\\<0.5 cm3) or mitral valve (\\<1.0 cm3) stenosis\n* Acute myocardial infarction within the prior 14 days\n* Fully paced cardiac rhythm\n* Known or suspected aortic dissection\n* Requiring preoperative intra-aortic balloon pump counterpulsation therapy\n* Contraindication to transesophageal echocardiography\n* Positive pregnancy test or breast feeding\n* Intolerance or allergy to calcium channel blockers\n* Allergy to soybean oil or egg lecithin\n* Any condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the patient from completing the study\n* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment"}, 'identificationModule': {'nctId': 'NCT00799604', 'acronym': 'SPRINT', 'briefTitle': 'Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Medicines Company'}, 'officialTitle': 'An Open-label Study in Patients Undergoing Cardiac Surgery to Evaluate the Effect of Bolus Clevidipine Administration (SPRINT)', 'orgStudyIdInfo': {'id': 'TMC-CLV-08-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'clevidipine', 'description': 'Patients were sequentially assigned to one of following three planned dose cohorts for Bolus 1 within the clevidipine arm:\n\n* Cohort 1: clevidipine 250 µg (0.5 mL)\n* Cohort 2: clevidipine 500 µg (1 mL)\n* Cohort 3: clevidipine 125 µg (0.25 mL or 0.5 mL of a 1:1 solution)', 'interventionNames': ['Drug: clevidipine']}], 'interventions': [{'name': 'clevidipine', 'type': 'DRUG', 'otherNames': ['clevidipine injectable emulsion', 'clevidipine emulsion', 'Cleviprex'], 'description': 'Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (\\<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).', 'armGroupLabels': ['clevidipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital, Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Albert T. Cheung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Edwin G. Avery, IV, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Medicines Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}