Trial Outcomes & Findings for Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE) (NCT NCT00666328)

Last Updated: 2014-08-29

Results Overview

The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

37 participants

Primary outcome timeframe

Within 30 minutes of study drug initiation

Results posted on

2014-08-29

Participant Flow

Patients considered for inclusion in this study were recruited from June 2008 through April 2010 primarily from hospital emergency departments and Neurology Intensive Care Units, having presented with acute hypertension and intracerebral hemorrhage (ICH). Enrollment targeted a subset of \~10 patients requiring intracranial pressure (ICP) monitoring.

Participants were required to have a systolic blood pressure (SBP) greater than 160 mm Hg both prior to enrollment and immediately prior to study drug initiation. Participants with SBP \</=160 mm Hg immediately prior to study drug did not receive clevidipine and were treated per standard of care.

Participant milestones

Participant milestones
Measure	Clevidipine Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
Overall Study STARTED	35
Overall Study Modified Intent To Treat (mITT)	33
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Clevidipine Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
Overall Study Death	2
Overall Study Lost to Follow-up	2
Overall Study No longer met eligibility criteria	1

Baseline Characteristics

Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clevidipine n=33 Participants mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses. Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
Age, Continuous	63.9 participants STANDARD_DEVIATION 12.14 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized White	21 participants n=5 Participants
Baseline Systolic Blood Pressure (SBP)	186.5 mm Hg STANDARD_DEVIATION 20.39 • n=5 Participants
Baseline Diastolic Blood Pressure (DBP)	85.7 mm Hg STANDARD_DEVIATION 12.89 • n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes of study drug initiation

Population: Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.

Outcome measures

Outcome measures
Measure	Clevidipine n=33 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine	5.5 minutes Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: Within 30 minutes of study drug initiation

Population: Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.

The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint.

Outcome measures

Outcome measures
Measure	Clevidipine n=33 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine	97 percent participants Interval 84.2 to 99.9

SECONDARY outcome

Timeframe: Baseline through 30 minutes post initiation of clevidipine infusion

Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period.

Outcome measures

Outcome measures
Measure	Clevidipine n=33 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 1 Min.	-2.2 percent change in SBP Standard Deviation 5.76
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 2 Min.	-4.7 percent change in SBP Standard Deviation 9.43
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 3 Min.	-5.9 percent change in SBP Standard Deviation 8.95
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 4 Min.	-8.5 percent change in SBP Standard Deviation 8.54
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 5 Min.	-9.8 percent change in SBP Standard Deviation 9.15
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 6 Min.	-11.3 percent change in SBP Standard Deviation 10.54
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 7 Min.	-13.9 percent change in SBP Standard Deviation 9.92
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 10 Min.	-14.0 percent change in SBP Standard Deviation 11.52
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 15 Min.	-17.4 percent change in SBP Standard Deviation 12.20
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 20 Min.	-17.4 percent change in SBP Standard Deviation 11.75
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 25 Min.	-18.9 percent change in SBP Standard Deviation 10.68
Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion Baseline Through Initial 30 Min.	-20.0 percent change in SBP Standard Deviation 8.16

SECONDARY outcome

Timeframe: Duration of the study drug infusion (up to 96 hours)

Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range.

Outcome measures

Outcome measures
Measure	Clevidipine n=33 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion	347.7 mm Hg × min/hr Standard Deviation 323.06

SECONDARY outcome

Timeframe: From study drug initiation through termination (up to 96 h)

Population: The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.

The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations \>24 hours across patients.

Outcome measures

Outcome measures
Measure	Clevidipine n=33 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine 0 -≤24 h of clevidipine infusion; n=33	51.91 percent time Standard Deviation 25.46
Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine 24-≤48 h of clevidipine infusion; n=8	61.12 percent time Standard Deviation 21.14
Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine 48-≤72 h of clevidipine infusion; n=4	46.94 percent time Standard Deviation 33.25
Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine 72-≤96 h of clevidipine infusion; n=1	65.91 percent time Standard Deviation 0.00

SECONDARY outcome

Timeframe: Up to 96 hours

Population: The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.

Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment

Outcome measures

Outcome measures
Measure	Clevidipine n=35 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Mean Dose of Clevidipine During the Treatment Period	260.28 milligrams (mg) Standard Deviation 321.68

SECONDARY outcome

Timeframe: Up to 96 hours

Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment

Outcome measures

Outcome measures
Measure	Clevidipine n=35 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Median Dose of Clevidipine During the Treatment Period	116.32 milligrams (mg) Interval 0.7 to 1213.8

SECONDARY outcome

Timeframe: Up to 96 hours

Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study.

Outcome measures

Outcome measures
Measure	Clevidipine n=33 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine	18 participants

SECONDARY outcome

Timeframe: From study drug initiation through each specified timepoint

Population: The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. Data for 33 of the 35 patients in the Safety population had data for the 30 minute time point used for this analysis.

Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes.

Outcome measures

Outcome measures
Measure	Clevidipine n=35 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 1 Min; n=35	-0.4 percent change Standard Deviation 5.02
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 2 Min; n=32	-0.7 percent change Standard Deviation 5.30
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 3 Min; n=35	-0.3 percent change Standard Deviation 6.41
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 4 Min; n=34	0.2 percent change Standard Deviation 8.22
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 5 Min; n=34	2.1 percent change Standard Deviation 8.25
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 6 Min; n=34	2.6 percent change Standard Deviation 7.73
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 7 Min; n=34	2.5 percent change Standard Deviation 9.30
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 10 Min; n=34	5.6 percent change Standard Deviation 13.67
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 15 Min; n=35	5.5 percent change Standard Deviation 15.65
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 20 Min, n=35	6.2 percent change Standard Deviation 15.44
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Study Drug Initiation Through Initial 25 Min; n=35	5.4 percent change Standard Deviation 14.50
Percent Change in Heart Rate During 30 of Initiation of Clevidipine Baseline Through Initial 30 Mins; n=33	4.9 percent change Standard Deviation 14.41

SECONDARY outcome

Timeframe: Within 30 minutes of the initiation of study drug infusion

Population: The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.

Outcome measures

Outcome measures
Measure	Clevidipine n=35 Participants Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion	0 percent participants

Adverse Events

Clevidipine

Serious events: 9 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clevidipine n=35 participants at risk Safety Population (n=35): This population is the primary population for the safety analyses. Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
Cardiac disorders Cardio-respiratory arrest	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Cardiac disorders Supraventricular tachycardia	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Nervous system disorders Brain oedema	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Nervous system disorders Cerebral haematoma	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Nervous system disorders Convulsion	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Nervous system disorders Haemorrhage intracranial	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Nervous system disorders Intraventricular haemorrhage	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.9% 1/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.

Other adverse events

Other adverse events
Measure	Clevidipine n=35 participants at risk Safety Population (n=35): This population is the primary population for the safety analyses. Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
Vascular disorders Hypotension	8.6% 3/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Blood and lymphatic system disorders Leukocytosis	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Gastrointestinal disorders Nausea	8.6% 3/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Gastrointestinal disorders Vomitting	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
General disorders Pyrexia	20.0% 7/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Investigations Blood creatinine increased	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Investigations Prothrombin time prolonged	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Investigations White blood cell count increased	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Metabolism and nutrition disorders Hyperglycaemia	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Metabolism and nutrition disorders Hypertriglyceridaemia	8.6% 3/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Metabolism and nutrition disorders Hypokalaemia	8.6% 3/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Metabolism and nutrition disorders Hypomagnesaemia	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Metabolism and nutrition disorders Hyposphataemia	11.4% 4/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Nervous system disorders Headache	14.3% 5/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Psychiatric disorders Agitation	11.4% 4/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Renal and urinary disorders Urinary retention	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.
Respiratory, thoracic and mediastinal disorders Rhonchi	5.7% 2/35 • AEs occurring from initiation of clevidipine infusion until up to 6 hours after cessation of clevidipine and SAEs that occurred from initiation of clevidipine infusion until up to 7 days after cessation of clevidipine infusion were assessed.

Additional Information

Jason Campagna. MD, PhD

The Medicines Company

Phone: 973-290-6199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The site agrees that it will not publish until the earlier of presentation and publication of results or until 12 months after study conclusion. The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted to the sponsor for review in order to allow sponsor time to file any patent applications. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER