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Sponsor decision
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Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
This was an open-label study to assess, in a stepwise approach across 4 age cohorts from oldest to youngest (birth to \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clevidipine | Experimental | An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol. The initial dose for each of the subsequent age cohorts could be modified if necessary, based on the recommendation of the Data and Safety Monitoring Board (DSMB). Following the initial dose, clevidipine will be up-titrated every 1.5 minutes, according to participant need, to achieve a systolic blood pressure (SBP) within the pre-specified SBP target range. Doses may be increased by less than doubling, and the time between dose adjustments may be lengthened, as the target blood pressure is approached. The infusion rate may be maintained for up to 96 hours, once the participant's SBP is within the target range, and titrated as necessary to maintain blood pressure within the range. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clevidipine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range | Efficacy: Median time to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart). The reason for initiating clevidipine administration was to keep blood pressure within a pre-specified range during surgery. Time to first achieve SBP target range within first 30 minutes. A target systolic blood pressure (SBP) range was specified for each patient prior to study drug initiation and could not be changed for the first 30 minutes of the treatment period. Adolescent patients received an initial weight-based dose of 0.4 μg/kg/minute, to be maintained for the first 1.5 minutes. Treatment period: from study drug initiation to termination of infusion (up to 96 hours) was: Phase 1: initial dosing (0 to 1.5 minutes); Phase 2: titration and maintenance phase (>1.5 minutes up to 96 hours); Phase 3: transition and termination phase where the study drug is ceased, and the patient is transitioned to an alternative IV or oral antihypertensive if required. | During the first 30 minutes of clevidipine infusion start (baseline). |
| Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion | Efficacy: Number and percentage of participants achieving the initial pre-specified target SBP range within first 30 minutes of clevidipine infusion. | During the first 30 minutes of clevidipine infusion start (baseline). |
| Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range | Efficacy: Total dose infused to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart) within the first 30 min. | During the first 30 minutes of clevidipine infusion start (baseline). |
| Pharmacology: Pharmacodynamic Variable -- Infusion Rate | Pharmacodynamic (PD) variable: infusion rate. A target systolic blood pressure (SBP) range was specified for each patient prior to study drug initiation by the Investigator and could not be changed for the first 30 minutes of the treatment period. Adolescent patients received an initial weight-based dose of 0.4 μg/kg/minute, to be maintained for the first 1.5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline) | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline). | From infusion start (baseline) to 30 minutes post baseline. |
| Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center | Stanford | California | 94305 | United States | ||
| Nationwide Children's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clevidipine | An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol. Following the initial dose, clevidipine was up-titrated every 1.5 minutes, according to participant need, to achieve a systolic blood pressure (SBP) within the pre-specified SBP target range. Doses could be increased by less than doubling, and the time between dose adjustments could be lengthened, as the target blood pressure was approached. The infusion rate may have been maintained for up to 96 hours, once the participant's SBP was within the target range, and titrated as necessary to maintain blood pressure within the range. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic and baseline characteristics of the baseline population: male and female adolescent patients (12 to less than 18 years) who required blood pressure management in the perioperative setting.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clevidipine | An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol. Following the initial dose, clevidipine will be up-titrated every 1.5 minutes, according to participant need, to achieve a systolic blood pressure (SBP) within the pre-specified SBP target range. Doses may be increased by less than doubling, and the time between dose adjustments may be lengthened, as the target blood pressure is approached. The infusion rate may be maintained for up to 96 hours, once the participant's SBP is within the target range, and titrated as necessary to maintain blood pressure within the range. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range | Efficacy: Median time to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart). The reason for initiating clevidipine administration was to keep blood pressure within a pre-specified range during surgery. Time to first achieve SBP target range within first 30 minutes. A target systolic blood pressure (SBP) range was specified for each patient prior to study drug initiation and could not be changed for the first 30 minutes of the treatment period. Adolescent patients received an initial weight-based dose of 0.4 μg/kg/minute, to be maintained for the first 1.5 minutes. Treatment period: from study drug initiation to termination of infusion (up to 96 hours) was: Phase 1: initial dosing (0 to 1.5 minutes); Phase 2: titration and maintenance phase (>1.5 minutes up to 96 hours); Phase 3: transition and termination phase where the study drug is ceased, and the patient is transitioned to an alternative IV or oral antihypertensive if required. | Safety population: All patients who received any study drug. | Posted | Median | 95% Confidence Interval | minutes | During the first 30 minutes of clevidipine infusion start (baseline). |
From start of infusion (baseline) to 7 days after the end of clevidipine infusion (minimum of approximately 7.5 days up to a maximum of approximately 11.5 days).
Safety population was used for analysis of safety. Treatment-emergent adverse events (TEAEs) were defined as those adverse events (AEs) occurring after study drug initiation that were either not present at baseline or were present at baseline but increased in severity after study drug initiation.
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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 | An initial clevidipine IV infusion dose for the adolescent cohort as specified per protocol. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
After the study completion for Cohort 1 (adolescent patients 12 to less than 18 years), the PIONEER study was put on partial clinical hold by the FDA; later, the study was terminated by the sponsor. Enrolment of the subsequent cohorts did not take place; results are presented for Cohort 1 only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | Chiesi Farmaceutici S.p.A. | + 39 0521 2791 | clinicaltrials_info@chiesi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 11, 2013 | Dec 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2014 | Dec 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
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| Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours). |
| Pharmacology: Clevidipine -- Tmax | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Tmax: The time it takes for a drug to reach the maximum concentration after administration of a drug. | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
| Pharmacology: Clevidipine -- Cmax | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Cmax: Highest concentration of a drug reached after administration. | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
| Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. AUC all: Area under the curve, represents the total drug exposure integrated over time. | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
| Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. AUC inf: Area under the curve of the blood concentration from time zero and extrapolated to infinity. | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
| Pharmacology: Clevidipine -- Volume of Distribution (Vd) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Vd: Volume of distribution is defined as the total amount of drug in the body divided by its concentration in plasma. | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
| Pharmacology: Clevidipine -- Total Clearance (CL) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. CL: Total Clearance is defined as the rate at which a drug is removed from plasma (mg/min) divided by the concentration of that drug in the plasma (mg/mL). | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
| Pharmacology: Clevidipine -- Half-Life (T1/2) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. T1/2: The half-life of a drug is the time it takes for the amount of a drug's active substance in your body to reduce by half. | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
Efficacy: Percent change from baseline (infusion start) in SBP at each hour after the first 30 minutes of clevidipine infusion up to the cessation of infusion (up to 6 hours from baseline). |
| At each hour from 30 minutes post-clevidipine infusion start (baseline) to 6 hours from baseline. |
| Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours | Efficacy: Percent change in SBP from baseline at each time point -- from cessation of study drug infusion and up to 12 hours. | During the first 12 hours (measured at each hour) after cessation of clevidipine infusion. |
| Efficacy: Number and Percentage of Patients Falling Below the Target Systolic Blood Pressure Range Lower Limit -- During the First 30 Minutes and During the Entire Drug Treatment Period of Clevidipine Infusion | Efficacy: Number and percentage of patients falling below the target systolic blood pressure range lower limit -- during the first 30 minutes and during the entire drug treatment period of clevidipine infusion. | During the first 30 minutes and during the entire drug treatment period (up to a maximum of 96 hours of clevidipine infusion). |
| Efficacy: Number and Percentage of Participants in Whom the SBP Was Within Target Range at Each Hour After the First 30 Minutes of Clevidipine Infusion (up to 6 Hours) | The number and percentage of participants in whom the SBP was within target range at each hour after the first 30 minutes of clevidipine infusion (up to 6 hours). | From 30 minutes after infusion start (baseline) and up to 6 hours post-clevidipine infusion. |
| Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion | Efficacy: Percent change from baseline in heart rate (HR). From infusion start (baseline) to 30 minutes post baseline. | From infusion start (baseline) to 30 minutes post baseline. |
| Efficacy: Percent Change From Baseline in Heart Rate (HR). | Efficacy: Percent change from baseline in heart rate (HR) -- From 30 Min to 6 Hours From Baseline. | At each hour after 30 minutes post-clevidipine infusion start (baseline) and up to 6 hours. |
| Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours | Efficacy: Percent change from baseline in heart rate. At each hour after cessation of clevidipine infusion (up to 12 hours). | At each hour after cessation of clevidipine infusion (up to 12 hours). |
| Efficacy: Number and Percentage of Participants Requiring Rescue Therapy | Efficacy: Number and percentage of participants who require rescue therapy (i.e. receive any alternative IV antihypertensive drug) at any time during the study drug treatment period. | Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline). |
| Efficacy: Number and Percentage of Participants Discontinuing Due to Adverse Events | Number and percentage of participants discontinuing the study due to adverse events. | Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline). |
| Columbus |
| Ohio |
| 43205 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Baseline Blood Pressure | Mean | Standard Deviation | mmHg |
|
| ID | Title | Description |
|---|
| OG000 | Clevidipine | An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol. |
|
|
| Primary | Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion | Efficacy: Number and percentage of participants achieving the initial pre-specified target SBP range within first 30 minutes of clevidipine infusion. | Safety population: All patients who received any study drug. This was the primary population used for the safety analyses. | Posted | Number | participants | During the first 30 minutes of clevidipine infusion start (baseline). |
|
|
|
| Primary | Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range | Efficacy: Total dose infused to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart) within the first 30 min. | Safety population: All patients who received any study drug. This was the primary population used for the safety analyses. | Posted | Median | Full Range | mg | During the first 30 minutes of clevidipine infusion start (baseline). |
|
|
|
| Primary | Pharmacology: Pharmacodynamic Variable -- Infusion Rate | Pharmacodynamic (PD) variable: infusion rate. A target systolic blood pressure (SBP) range was specified for each patient prior to study drug initiation by the Investigator and could not be changed for the first 30 minutes of the treatment period. Adolescent patients received an initial weight-based dose of 0.4 μg/kg/minute, to be maintained for the first 1.5 minutes. | Safety population: All patients who received any study drug. This was the primary population used for the safety analyses. | Posted | Median | Full Range | microgram/kg/min | Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours). |
|
|
|
| Primary | Pharmacology: Clevidipine -- Tmax | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Tmax: The time it takes for a drug to reach the maximum concentration after administration of a drug. | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | minutes | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
|
|
|
| Primary | Pharmacology: Clevidipine -- Cmax | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Cmax: Highest concentration of a drug reached after administration. | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | ng/mL | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
|
|
|
| Primary | Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. AUC all: Area under the curve, represents the total drug exposure integrated over time. | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | min*ng/mL | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
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| Primary | Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. AUC inf: Area under the curve of the blood concentration from time zero and extrapolated to infinity. | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | min*ng/mL | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
|
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|
| Primary | Pharmacology: Clevidipine -- Volume of Distribution (Vd) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Vd: Volume of distribution is defined as the total amount of drug in the body divided by its concentration in plasma. | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | mL/kg | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
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| Primary | Pharmacology: Clevidipine -- Total Clearance (CL) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. CL: Total Clearance is defined as the rate at which a drug is removed from plasma (mg/min) divided by the concentration of that drug in the plasma (mg/mL). | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | mL/min/kg | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
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| Primary | Pharmacology: Clevidipine -- Half-Life (T1/2) | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. T1/2: The half-life of a drug is the time it takes for the amount of a drug's active substance in your body to reduce by half. | PK/PD population: All patients who received any study drug, had at least one documented and evaluable blood concentration and/or SBP observation and documented dose records. | Posted | Mean | Standard Deviation | min | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). |
|
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| Secondary | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline) | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline). | Safety population: All patients who received any study drug. | Posted | Mean | Standard Deviation | percent change from baseline | From infusion start (baseline) to 30 minutes post baseline. |
|
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| Secondary | Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline) | Efficacy: Percent change from baseline (infusion start) in SBP at each hour after the first 30 minutes of clevidipine infusion up to the cessation of infusion (up to 6 hours from baseline). | Safety population: All patients who received any study drug. | Posted | Mean | Standard Deviation | percent change from baseline | At each hour from 30 minutes post-clevidipine infusion start (baseline) to 6 hours from baseline. |
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| Secondary | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours | Efficacy: Percent change in SBP from baseline at each time point -- from cessation of study drug infusion and up to 12 hours. | Safety population: All patients who received any study drug. | Posted | Mean | Standard Deviation | percent change from baseline | During the first 12 hours (measured at each hour) after cessation of clevidipine infusion. |
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| Secondary | Efficacy: Number and Percentage of Patients Falling Below the Target Systolic Blood Pressure Range Lower Limit -- During the First 30 Minutes and During the Entire Drug Treatment Period of Clevidipine Infusion | Efficacy: Number and percentage of patients falling below the target systolic blood pressure range lower limit -- during the first 30 minutes and during the entire drug treatment period of clevidipine infusion. | Safety population: All patients who received any study drug. | Posted | Number | participants | During the first 30 minutes and during the entire drug treatment period (up to a maximum of 96 hours of clevidipine infusion). |
|
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| Secondary | Efficacy: Number and Percentage of Participants in Whom the SBP Was Within Target Range at Each Hour After the First 30 Minutes of Clevidipine Infusion (up to 6 Hours) | The number and percentage of participants in whom the SBP was within target range at each hour after the first 30 minutes of clevidipine infusion (up to 6 hours). | Safety population: All patients who received any study drug. | Posted | Number | participants | From 30 minutes after infusion start (baseline) and up to 6 hours post-clevidipine infusion. |
|
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| Secondary | Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion | Efficacy: Percent change from baseline in heart rate (HR). From infusion start (baseline) to 30 minutes post baseline. | Safety population: All patients who received any study drug. | Posted | Mean | Standard Deviation | Percent change in HR from baseline | From infusion start (baseline) to 30 minutes post baseline. |
|
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| Secondary | Efficacy: Percent Change From Baseline in Heart Rate (HR). | Efficacy: Percent change from baseline in heart rate (HR) -- From 30 Min to 6 Hours From Baseline. | Safety population: All patients who received any study drug. | Posted | Mean | Standard Deviation | Percent change in HR from baseline | At each hour after 30 minutes post-clevidipine infusion start (baseline) and up to 6 hours. |
|
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| Secondary | Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours | Efficacy: Percent change from baseline in heart rate. At each hour after cessation of clevidipine infusion (up to 12 hours). | Safety population: All patients who received any study drug. | Posted | Mean | Standard Deviation | Percent change in HR from baseline | At each hour after cessation of clevidipine infusion (up to 12 hours). |
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| Secondary | Efficacy: Number and Percentage of Participants Requiring Rescue Therapy | Efficacy: Number and percentage of participants who require rescue therapy (i.e. receive any alternative IV antihypertensive drug) at any time during the study drug treatment period. | Safety population: All patients who received any study drug. | Posted | Number | participants | Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline). |
|
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| Secondary | Efficacy: Number and Percentage of Participants Discontinuing Due to Adverse Events | Number and percentage of participants discontinuing the study due to adverse events. | Safety population: All patients who received any study drug. | Posted | Number | participants | Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline). |
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 21 |
| 21 |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
|
Not provided
Not provided
|
| 4.5 minutes |
|
|
| 7.5 minutes |
|
|
| 10.5 minutes |
|
|
| 15 minutes |
|
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| 21 minutes |
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| 25.5 minutes |
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| 30 minutes |
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| 2 hours |
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| 3 hours |
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| 4 hours |
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| 5 hours |
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| 6 hours |
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| 3 hours |
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| 4 hours |
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| 5 hours |
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| 6 hours |
|
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| 7 hours |
|
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| 8 hours |
|
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| 9 hours |
|
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| 10 hours |
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| 11 hours |
|
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| 12 hours |
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| SBP within target range at 3 hour |
|
|
| SBP within target range at 4 hour |
|
|
| SBP within target range at 5 hour |
|
|
| SBP within target range at 6 hour |
|
|
|
| 4.5 minutes |
|
|
| 6 minutes |
|
|
| 7.5 minutes |
|
|
| 9 minutes |
|
|
| 10.5 minutes |
|
|
| 12 minutes |
|
|
| 13.5 minutes |
|
|
| 15 minutes |
|
|
| 16.5 minutes |
|
|
| 18 minutes |
|
|
| 19.5 minutes |
|
|
| 21 minutes |
|
|
| 22.5 minutes |
|
|
| 24.0 minutes |
|
|
| 25.5 minutes |
|
|
| 27 minutes |
|
|
| 28.5 minutes |
|
|
| 30 minutes |
|
|
|
| 3 hours |
|
|
| 4 hours |
|
|
| 5 hours |
|
|
| 6 hours |
|
|
|
| 3 hours |
|
|
| 4 hours |
|
|
| 5 hours |
|
|
| 6 hours |
|
|
| 7 hours |
|
|
| 8 hours |
|
|
| 9 hours |
|
|
| 10 hours |
|
|
| 11 hours |
|
|
| 12 hours |
|
|