Trial Outcomes & Findings for Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER) (NCT NCT01938547)
NCT ID: NCT01938547
Last Updated: 2025-04-17
Results Overview
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.
TERMINATED
PHASE4
22 participants
During the first 30 minutes of clevidipine infusion start (baseline).
2025-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Baseline characteristics by cohort
| Measure |
Clevidipine
n=21 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
15.0 years
STANDARD_DEVIATION 1.56 • n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
|
Height
|
158.20 cm
STANDARD_DEVIATION 13.46 • n=99 Participants
|
|
Weight
|
51.49 kg
STANDARD_DEVIATION 13.47 • n=99 Participants
|
|
Baseline Blood Pressure
Systolic
|
111.0 mmHg
STANDARD_DEVIATION 17.67 • n=99 Participants
|
|
Baseline Blood Pressure
Diastolic
|
63.4 mmHg
STANDARD_DEVIATION 5.84 • n=99 Participants
|
PRIMARY outcome
Timeframe: During the first 30 minutes of clevidipine infusion start (baseline).Population: Safety population: All patients who received any study drug.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range
|
7.9 minutes
Interval 7.2 to 10.5
|
PRIMARY outcome
Timeframe: During the first 30 minutes of clevidipine infusion start (baseline).Population: Safety population: All patients who received any study drug. This was the primary population used for the safety analyses.
Efficacy: Number and percentage of participants achieving the initial pre-specified target SBP range within first 30 minutes of clevidipine infusion.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion
|
21 participants
|
PRIMARY outcome
Timeframe: During the first 30 minutes of clevidipine infusion start (baseline).Population: Safety population: All patients who received any study drug. This was the primary population used for the safety analyses.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range
|
0.28 mg
Interval 0.02 to 0.91
|
PRIMARY outcome
Timeframe: Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours).Population: Safety population: All patients who received any study drug. This was the primary population used for the safety analyses.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Pharmacodynamic Variable -- Infusion Rate
|
0.80 microgram/kg/min
Interval 0.4 to 3.2
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Tmax
|
51 minutes
Standard Deviation 47
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Cmax
|
14.0 ng/mL
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall)
|
1598 min*ng/mL
Standard Deviation 1540
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf)
|
1598 min*ng/mL
Standard Deviation 1540
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Volume of Distribution (Vd)
|
789 mL/kg
Standard Deviation 1165
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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).
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Total Clearance (CL)
|
113 mL/min/kg
Standard Deviation 54
|
PRIMARY outcome
Timeframe: From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours).Population: 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.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Pharmacology: Clevidipine -- Half-Life (T1/2)
|
4.3 min
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: From infusion start (baseline) to 30 minutes post baseline.Population: Safety population: All patients who received any study drug.
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline).
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
1.5 minutes
|
-0.6 percent change from baseline
Standard Deviation 9.53
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
3.0 minutes
|
-3.4 percent change from baseline
Standard Deviation 8.19
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
4.5 minutes
|
-4.7 percent change from baseline
Standard Deviation 6.68
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
7.5 minutes
|
-11.6 percent change from baseline
Standard Deviation 7.18
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
10.5 minutes
|
-18.3 percent change from baseline
Standard Deviation 6.89
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
15 minutes
|
-18.2 percent change from baseline
Standard Deviation 8.09
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
21 minutes
|
-18.6 percent change from baseline
Standard Deviation 8.28
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
25.5 minutes
|
-19.3 percent change from baseline
Standard Deviation 9.18
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline)
30 minutes
|
-20.8 percent change from baseline
Standard Deviation 7.62
|
SECONDARY outcome
Timeframe: At each hour from 30 minutes post-clevidipine infusion start (baseline) to 6 hours from baseline.Population: Safety population: All patients who received any study drug.
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).
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
1 hour
|
-22.9 percent change from baseline
Standard Deviation 9.47
|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
1.5 hours
|
-18.6 percent change from baseline
Standard Deviation 12.52
|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
3 hours
|
-15.3 percent change from baseline
Standard Deviation 6.47
|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
4 hours
|
-21.5 percent change from baseline
Standard Deviation 9.20
|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
5 hours
|
-21.4 percent change from baseline
Standard Deviation 14.07
|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
2 hours
|
-24.1 percent change from baseline
Standard Deviation 11.33
|
|
Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline)
6 hours
|
-14.29 percent change from baseline
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: During the first 12 hours (measured at each hour) after cessation of clevidipine infusion.Population: Safety population: All patients who received any study drug.
Efficacy: Percent change in SBP from baseline at each time point -- from cessation of study drug infusion and up to 12 hours.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
1 hour
|
-12.2 percent change from baseline
Standard Deviation 22.92
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
2 hours
|
-12.1 percent change from baseline
Standard Deviation 21.83
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
3 hours
|
-4.9 percent change from baseline
Standard Deviation 25.07
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
4 hours
|
-2.8 percent change from baseline
Standard Deviation 23.20
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
5 hours
|
-1.1 percent change from baseline
Standard Deviation 21.00
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
6 hours
|
0.5 percent change from baseline
Standard Deviation 21.76
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
7 hours
|
1.2 percent change from baseline
Standard Deviation 20.68
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
8 hours
|
-2.7 percent change from baseline
Standard Deviation 20.79
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
9 hours
|
1.7 percent change from baseline
Standard Deviation 24.21
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
10 hours
|
0.9 percent change from baseline
Standard Deviation 19.48
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
11 hours
|
-7.1 percent change from baseline
Standard Deviation 18.48
|
|
Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours
12 hours
|
-4.0 percent change from baseline
Standard Deviation 19.83
|
SECONDARY outcome
Timeframe: During the first 30 minutes and during the entire drug treatment period (up to a maximum of 96 hours of clevidipine infusion).Population: Safety population: All patients who received any study drug.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
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
First 30 minutes of clevidipine infusion
|
1 participants
|
|
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
Up to 96 hours of clevidipine infusion
|
5 participants
|
SECONDARY outcome
Timeframe: From 30 minutes after infusion start (baseline) and up to 6 hours post-clevidipine infusion.Population: Safety population: All patients who received any study drug.
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).
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
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)
SBP within target range at 1 hour
|
8 participants
|
|
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)
SBP within target range at 2 hour
|
5 participants
|
|
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)
SBP within target range at 3 hour
|
5 participants
|
|
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)
SBP within target range at 4 hour
|
1 participants
|
|
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)
SBP within target range at 5 hour
|
2 participants
|
|
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)
SBP within target range at 6 hour
|
0 participants
|
SECONDARY outcome
Timeframe: From infusion start (baseline) to 30 minutes post baseline.Population: Safety population: All patients who received any study drug.
Efficacy: Percent change from baseline in heart rate (HR). From infusion start (baseline) to 30 minutes post baseline.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
1.5 minutes
|
5.7 Percent change in HR from baseline
Standard Deviation 16.89
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
3 minutes
|
0.8 Percent change in HR from baseline
Standard Deviation 6.80
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
4.5 minutes
|
0.7 Percent change in HR from baseline
Standard Deviation 7.64
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
6 minutes
|
2.2 Percent change in HR from baseline
Standard Deviation 7.61
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
7.5 minutes
|
5.4 Percent change in HR from baseline
Standard Deviation 10.12
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
9 minutes
|
12.2 Percent change in HR from baseline
Standard Deviation 17.97
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
10.5 minutes
|
10.6 Percent change in HR from baseline
Standard Deviation 15.29
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
12 minutes
|
11.1 Percent change in HR from baseline
Standard Deviation 14.72
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
13.5 minutes
|
10.7 Percent change in HR from baseline
Standard Deviation 14.02
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
15 minutes
|
13.7 Percent change in HR from baseline
Standard Deviation 19.63
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
16.5 minutes
|
14.8 Percent change in HR from baseline
Standard Deviation 20.38
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
18 minutes
|
12.7 Percent change in HR from baseline
Standard Deviation 16.54
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
19.5 minutes
|
13.0 Percent change in HR from baseline
Standard Deviation 14.48
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
21 minutes
|
12.2 Percent change in HR from baseline
Standard Deviation 13.59
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
22.5 minutes
|
14.7 Percent change in HR from baseline
Standard Deviation 15.81
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
24.0 minutes
|
12.9 Percent change in HR from baseline
Standard Deviation 13.95
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
25.5 minutes
|
15.2 Percent change in HR from baseline
Standard Deviation 16.26
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
27 minutes
|
13.5 Percent change in HR from baseline
Standard Deviation 14.10
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
28.5 minutes
|
14.9 Percent change in HR from baseline
Standard Deviation 13.69
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion
30 minutes
|
13.0 Percent change in HR from baseline
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: At each hour after 30 minutes post-clevidipine infusion start (baseline) and up to 6 hours.Population: Safety population: All patients who received any study drug.
Efficacy: Percent change from baseline in heart rate (HR) -- From 30 Min to 6 Hours From Baseline.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR).
1 hour
|
11.5 Percent change in HR from baseline
Standard Deviation 16.13
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR).
2 hours
|
10.68 Percent change in HR from baseline
Standard Deviation 12.89
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR).
3 hours
|
8.5 Percent change in HR from baseline
Standard Deviation 17.64
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR).
4 hours
|
13.2 Percent change in HR from baseline
Standard Deviation 16.20
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR).
5 hours
|
11.3 Percent change in HR from baseline
Standard Deviation 12.26
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR).
6 hours
|
12.0 Percent change in HR from baseline
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: At each hour after cessation of clevidipine infusion (up to 12 hours).Population: Safety population: All patients who received any study drug.
Efficacy: Percent change from baseline in heart rate. At each hour after cessation of clevidipine infusion (up to 12 hours).
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
1 hour
|
11.4 Percent change in HR from baseline
Standard Deviation 17.03
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
2 hours
|
13.2 Percent change in HR from baseline
Standard Deviation 17.88
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
3 hours
|
10.4 Percent change in HR from baseline
Standard Deviation 17.30
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
4 hours
|
17.0 Percent change in HR from baseline
Standard Deviation 29.48
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
5 hours
|
11.2 Percent change in HR from baseline
Standard Deviation 20.83
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
6 hours
|
12.3 Percent change in HR from baseline
Standard Deviation 23.55
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
7 hours
|
13.48 Percent change in HR from baseline
Standard Deviation 22.33
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
8 hours
|
12.0 Percent change in HR from baseline
Standard Deviation 22.71
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
9 hours
|
19.8 Percent change in HR from baseline
Standard Deviation 31.63
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
10 hours
|
16.8 Percent change in HR from baseline
Standard Deviation 24.90
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
11 hours
|
15.9 Percent change in HR from baseline
Standard Deviation 28.31
|
|
Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours
12 hours
|
13.0 Percent change in HR from baseline
Standard Deviation 21.54
|
SECONDARY outcome
Timeframe: Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline).Population: Safety population: All patients who received any study drug.
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.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Number and Percentage of Participants Requiring Rescue Therapy
|
0 participants
|
SECONDARY outcome
Timeframe: Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline).Population: Safety population: All patients who received any study drug.
Number and percentage of participants discontinuing the study due to adverse events.
Outcome measures
| Measure |
Clevidipine
n=21 Participants
An initial clevidipine IV infusion dose for the adolescent cohort has been specified per protocol.
|
|---|---|
|
Efficacy: Number and Percentage of Participants Discontinuing Due to Adverse Events
|
0 participants
|
Adverse Events
Clevidipine
Serious adverse events
| Measure |
Clevidipine
n=21 participants at risk
An initial clevidipine IV infusion dose for the adolescent cohort as specified per protocol.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
4.8%
1/21 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Clevidipine
n=21 participants at risk
An initial clevidipine IV infusion dose for the adolescent cohort as specified per protocol.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
57.1%
12/21 • Number of events 12 • 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.
|
|
Gastrointestinal disorders
Constipation
|
47.6%
10/21 • Number of events 10 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
9/21 • Number of events 9 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
3/21 • Number of events 3 • 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.
|
|
Nervous system disorders
Dizziness
|
33.3%
7/21 • Number of events 7 • 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.
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 4 • 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.
|
|
Nervous system disorders
Hypoaesthesia
|
9.5%
2/21 • Number of events 2 • 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.
|
|
Nervous system disorders
Sedation
|
9.5%
2/21 • Number of events 2 • 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.
|
|
General disorders
Pyrexia
|
23.8%
5/21 • Number of events 5 • 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.
|
|
General disorders
Fatigue
|
9.5%
2/21 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
19.0%
4/21 • Number of events 4 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
3/21 • Number of events 3 • 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.
|
Additional Information
Clinical Trial Transparency
Chiesi Farmaceutici S.p.A.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place