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The purpose of this study was to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure >160 mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).
This was a multicenter, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly control acute hypertension in patients with intracerebral hemorrhage. Informed consent was obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures. At screening, a clinical and neurological examination was carried out. For the purposes of this study, acute hypertension was defined as SBP >160 mmHg immediately prior to initiation of study drug. Approximately 30 to 40 patients with acute intracerebral hemorrhage (ICH) were planned to be enrolled with approximately 10 patients requiring monitoring of intracranial pressure (ICP). Infusion of study drug was initiated within 12 hours of ICH symptom onset. All eligible patients enrolled received clevidipine in an open label manner. Clevidipine was to be infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed, to obtain the target SBP range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. During the first 30 minutes, if the desired blood pressure lowering effect was not attained or maintained, an alternative intravenous (IV) antihypertensive agent(s), advised to be a different class other than calcium channel blockers, could be used with or without stopping the clevidipine infusion. The clevidipine infusion could continue for up to a maximum of 96 hours. Twenty-four hour follow-up computerized tomography (CT) scan results were recorded, including measurement of intracerebral hematoma volumes. Assessment of safety was performed throughout the treatment period and until 6 hours after termination of study drug. Patients were followed for 7 days following termination of the clevidipine infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clevidipine | Experimental | This will be a single-arm study with no reference therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clevidipine | Drug | Clevidipine injectable emulsion (0.5 mg/mL) in 20% lipid emulsion in 100 mL bottles was administered intravenously to all patients via a single dedicated line. Clevidipine was infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed to obtain the target systolic blood pressure (SBP) range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. The clevidipine infusion rate could be increased or decreased to maintain systolic blood pressure for up to a maximum of 96 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine | 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. | Within 30 minutes of study drug initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo Graffagnino, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010-2975 | United States | ||
| The Queens Medical Center |
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 \
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Within 30 minutes of study drug initiation |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes 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. | Baseline through 30 minutes post initiation of clevidipine infusion |
| 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 | 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. | Duration of the study drug infusion (up to 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 | 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. | From study drug initiation through termination (up to 96 h) |
| Mean Dose of Clevidipine During the Treatment Period | Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment | Up to 96 hours |
| Median Dose of Clevidipine During the Treatment Period | Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment | Up to 96 hours |
| Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine | 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. | Up to 96 hours |
| Percent Change in Heart Rate During 30 of Initiation of Clevidipine | 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. | From study drug initiation through each specified timepoint |
| The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion | Within 30 minutes of the initiation of study drug infusion |
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| The John Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Maine Medical Center | Portland | Massachusetts | 04102 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Guilford Neurologic - Moses H Cone Health System | Greensboro | North Carolina | 27405 | United States |
| Cleveland Clinic Hospitals | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University Stroke Research | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The University Health Science Center at S.A. | San Antonio | Texas | 78229-3900 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Universitätsklinikum Leipzig | Liebigstraße 22a | Leipzig | D-04103 | Germany |
| Universitatsklinikum Erlangen | Erlangen | D91054 | Germany |
| Universitatsklinikum Heidelberg | Heidelberg | D69120 | Germany |
| Modified Intent To Treat (mITT) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clevidipine | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Baseline Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mm Hg |
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| Baseline Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mm Hg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine | 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. | 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. | Posted | Median | 95% Confidence Interval | minutes | Within 30 minutes of study drug initiation |
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| Secondary | Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine | 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. | 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. | Posted | Number | 95% Confidence Interval | percent participants | Within 30 minutes of study drug initiation |
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| Secondary | Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes 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. | Posted | Mean | Standard Deviation | percent change in SBP | Baseline through 30 minutes post initiation of clevidipine infusion |
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| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | mm Hg × min/hr | Duration of the study drug infusion (up to 96 hours) |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent time | From study drug initiation through termination (up to 96 h) |
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| Secondary | Mean Dose of Clevidipine During the Treatment Period | Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment | 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. | Posted | Mean | Standard Deviation | milligrams (mg) | Up to 96 hours |
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| Secondary | Median Dose of Clevidipine During the Treatment Period | Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment | Posted | Median | Inter-Quartile Range | milligrams (mg) | Up to 96 hours |
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| Secondary | Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine | 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. | 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. | Posted | Number | participants | Up to 96 hours |
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| Secondary | Percent Change in Heart Rate During 30 of Initiation of Clevidipine | 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. | 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. | Posted | Mean | Standard Deviation | percent change | From study drug initiation through each specified timepoint |
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| Secondary | The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion | 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. | Posted | Number | percent participants | Within 30 minutes of the initiation of study drug infusion |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clevidipine | 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. | 9 | 35 | 27 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment | unrelated |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment | unrelated |
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| Brain oedema | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | unlikely related |
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| Cerebral haematoma | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | unrelated |
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| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | unlikely related |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | unlikely related |
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| Intraventricular haemorrhage | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | unrelated |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment | unrelated |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment | 1 patient (2.86%) discontinued study drug due to a TEAE of hypotension(baseline SBP 82/47 mm Hg). This was a non-serious AE moderate in severity and related to study treatment. The AE lasted 51 min and resolved 29 minutes after study drug withdrawal. |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA 11.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyposphataemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Campagna. MD, PhD | The Medicines Company | 973-290-6199 | jason.campagna@themedco.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
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| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Pacific Islander |
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| White |
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