Trial · NCT01938547
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
NCT01938547, Phase 4, Terminated, Chiesi Farmaceutici S.p.A.; results first posted 2025-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER). Trials, record NCT01938547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01938547
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
- NCT number
- NCT01938547
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 22 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Pediatric Perioperative Blood Pressure Management
- Interventions
- clevidipine
- First posted
- 2013-09-10
- Last updated
- 2025-04-17
- Results first posted
- 2025-04-17
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range | During the first 30 minutes of clevidipine infusion start (baseline). | 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. |
| Primary | Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion | During the first 30 minutes of clevidipine infusion start (baseline). | Efficacy: Number and percentage of participants achieving the initial pre-specified target SBP range within first 30 minutes of clevidipine infusion. |
| Primary | Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range | During the first 30 minutes of clevidipine infusion start (baseline). | 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. |
| Primary | Pharmacology: Pharmacodynamic Variable -- Infusion Rate | Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours). | 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. |
| Primary | Pharmacology: Clevidipine -- Tmax | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. |
| Primary | Pharmacology: Clevidipine -- Cmax | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. |
| Primary | Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. |
| Primary | Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. |
| Primary | Pharmacology: Clevidipine -- Volume of Distribution (Vd) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. |
| Primary | Pharmacology: Clevidipine -- Total Clearance (CL) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range | During the first 30 minutes of clevidipine infusion start (baseline). | Safety population: All patients who received any study drug. | minutes | MEDIAN |
| PRIMARY | Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion | During the first 30 minutes of clevidipine infusion start (baseline). | Safety population: All patients who received any study drug. This was the primary population used for the safety analyses. | participants | NUMBER |
| PRIMARY | Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range | During the first 30 minutes of clevidipine infusion start (baseline). | Safety population: All patients who received any study drug. This was the primary population used for the safety analyses. | mg | MEDIAN |
| PRIMARY | Pharmacology: Pharmacodynamic Variable -- Infusion Rate | Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours). | Safety population: All patients who received any study drug. This was the primary population used for the safety analyses. | microgram/kg/min | MEDIAN |
| PRIMARY | Pharmacology: Clevidipine -- Tmax | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. | minutes | MEAN |
| PRIMARY | Pharmacology: Clevidipine -- Cmax | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. | ng/mL | MEAN |
| PRIMARY | Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. | min*ng/mL | MEAN |
| PRIMARY | Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. | min*ng/mL | MEAN |
| PRIMARY | Pharmacology: Clevidipine -- Volume of Distribution (Vd) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. | mL/kg | MEAN |
| PRIMARY | Pharmacology: Clevidipine -- Total Clearance (CL) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | 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. | mL/min/kg | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range | Clevidipine | 7.9 | 95% Confidence Interval 7.2 to 10.5 | minutes | |
| Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion | Clevidipine | 21 | participants | ||
| Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range | Clevidipine | 0.28 | Full Range 0.02 to 0.91 | mg | |
| Pharmacology: Pharmacodynamic Variable -- Infusion Rate | Clevidipine | 0.80 | Full Range 0.4 to 3.2 | microgram/kg/min | |
| Pharmacology: Clevidipine -- Tmax | Clevidipine | 51 | Standard Deviation 47 | minutes | |
| Pharmacology: Clevidipine -- Cmax | Clevidipine | 14.0 | Standard Deviation 5.6 | ng/mL | |
| Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall) | Clevidipine | 1598 | Standard Deviation 1540 | min*ng/mL | |
| Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf) | Clevidipine | 1598 | Standard Deviation 1540 | min*ng/mL | |
| Pharmacology: Clevidipine -- Volume of Distribution (Vd) | Clevidipine | 789 | Standard Deviation 1165 | mL/kg | |
| Pharmacology: Clevidipine -- Total Clearance (CL) | Clevidipine | 113 | Standard Deviation 54 | mL/min/kg |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clevidipine | 22 | |
| Overall Study | COMPLETED | Clevidipine | 21 | |
| Overall Study | NOT COMPLETED | Clevidipine | 1 |
Source ClinicalTrials.gov
Adverse events13
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Clevidipine | 12 | 21 | 12 |
| other | Constipation | Gastrointestinal disorders | Clevidipine | 10 | 21 | 10 |
| other | Vomiting | Gastrointestinal disorders | Clevidipine | 9 | 21 | 9 |
| other | Abdominal Pain | Gastrointestinal disorders | Clevidipine | 3 | 21 | 3 |
| other | Dizziness | Nervous system disorders | Clevidipine | 7 | 21 | 7 |
| other | Headache | Nervous system disorders | Clevidipine | 4 | 21 | 4 |
| other | Hypoaesthesia | Nervous system disorders | Clevidipine | 2 | 21 | 2 |
| other | Sedation | Nervous system disorders | Clevidipine | 2 | 21 | 2 |
| other | Pyrexia | General disorders | Clevidipine | 5 | 21 | 5 |
| other | Fatigue | General disorders | Clevidipine | 2 | 21 | 2 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clevidipine | 0 | 21 |
| Total, other adverse events | Clevidipine | 21 | 21 |
| Total, serious adverse events | Clevidipine | 1 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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