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NCT01938547 · ClinicalTrials.gov registry record · Phase 4
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
A Phase 4 study, sponsored by Chiesi Farmaceutici S.p.A..
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT01938547: Clinical Trial Phase 4 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT01938547 is a Phase 4 study that was terminated before completion, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01938547, a Phase 4 study, was terminated before completion, sponsored by Chiesi Farmaceutici S.p.A..
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 patient
Interventions
- DRUG clevidipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-03-17 |
| Est. Completion | 2024-02-20 |
| Phase | Phase 4 |
Why NCT01938547 stopped before completion
NCT01938547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which clevidipine is the first listed.
NCT01938547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01938547 about?
NCT01938547 is a clinical study titled "Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)". 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.
What is the current status of trial NCT01938547?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2014-03-17. Estimated completion is 2024-02-20.
What interventions are being tested in trial NCT01938547?
The interventions under investigation include: clevidipine (DRUG).
Who is sponsoring clinical trial NCT01938547?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01938547's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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