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

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy, safety and dosing of an intravenous (IV) infusion of clevidipine for blood pressure (BP) management in pediatric participants in the perioperative setting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.; The Medicines Company
• Treatments: Clevidipine

Criteria

Inclusion Criteria:

• Less than 18 years of age

• Written informed consent obtained before initiation of any study-related procedures

• The enrolling physician determines that the participant will likely require a 15% reduction in BP during the perioperative course

• Intra-arterial line is available for blood pressure monitoring

• Surgical procedure requiring a minimum of 1 hour of anesthesia, in which IV antihypertensive therapy to control BP for at least 30 minutes is anticipated

Exclusion Criteria:

• Administration of an IV or oral antihypertensive agent within 2 hours prior to study drug administration

• Congenital heart disease described as single ventricle

• Evidence of liver failure, severe liver disease, pulmonary disease (e.g. uncontrolled asthma), hyperlipidemia, lipoid nephrosis, lipid dysfunction or acute pancreatitis

• Allergy to soya bean oil or egg lecithin

• Known to be intolerant to calcium channel blockers

• Hemophilia or blood coagulation disorders

• Any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures

• Clinically significant abnormal physical findings at the screening evaluation

• Any serious surgical or medical condition which, in the opinion of the investigator, is likely to interfere with study procedures or with the pharmacokinetics or pharmacodynamics of the study drug

• Participant is terminally ill (death likely to occur within 48 hours)

• Use of Methylphenidate, calcium channel blockers, Aripiprazole and other atypical anti- psychotics and antihypertensives used for BP control within 2 hours prior to study drug initiation

• Positive serum or urine pregnancy test for any female of child bearing potential

• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

• Participants who, for any reason, are deemed by the Investigator to be inappropriate for this study

• Participant is a relative of the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the study