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

Launched by CHIESI FARMACEUTICI S.P.A. · Sep 4, 2013

Keywords

ClinConnect Summary

This was an open-label study to assess, in a stepwise approach across 4 age cohorts from oldest to youngest (birth to \

Gender

ALL

Eligibility 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