NCT01938547

Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)

Open Label Study to Assess the Efficacy, Safety and Dosing of Clevidipine in Pediatric Patients Undergoing Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was an open-label study to assess, in a stepwise approach across 4 age cohorts from oldest to youngest (birth to \<age 18), the efficacy and safety of clevidipine exposure for a minimum of 30 minutes and up to a maximum of 96 hours in pediatric participants undergoing a surgical procedure with anesthesia for greater than or equal to 1 hour and for whom parenteral IV infusion of antihypertensive therapy for the management of blood pressure was expected. The reason for initiating clevidipine administration was to keep blood pressure within a pre-specified range during surgery. After the study completion for Cohort 1 (adolescent patients 12 to less than 18 years), the PIONEER study was placed 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.

Conditions

• Pediatric Perioperative Blood Pressure Management

Interventions

Type	Name	Description
DRUG	clevidipine

Timeline

• Start date: 2014-03-17
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2013-09-10
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study