Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Patients Undergoing Surgery (PIONEER)
Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Perioperative Blood Pressure Management
Intervention: clevidipine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The Medicines Company Official(s) and/or principal investigator(s): Joseph D Tobias, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital
Overall contact: Hassan Danesi, MD, Phone: 973-290-6173, Email: hassan.danesi@themedco.com
Summary
To evaluate the efficacy, safety and dosing of an intravenous (IV) infusion of clevidipine
for blood pressure (BP) management in pediatric patients in the perioperative setting.
Clinical Details
Official title: Open Label Study to Assess the Efficacy, Safety and Dosing of Clevidipine in Pediatric Patients Undergoing Surgery
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy: Median time to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart)Efficacy: Dose to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart) Efficacy: Percentage of patients achieving the initial pre-specified target SBP range Pharmacology: Pharmacokinetic variables [half-life, Area Under the Curve (AUC), volume of distribution, clearance] established by noncompartmental analysis or sparse population methodology Pharmacology: Pharmacodynamic variables (relationship between change from baseline in SBP vs. blood concentration and infusion rate) Safety: Safety of a prolonged infusion of clevidipine assessed through clinical laboratory parameters, adverse events and serious adverse events (SAEs)
Secondary outcome: Efficacy: The percentage of patients who reach the initial pre-specified target SBP range without falling below the lower limit of the pre-specified target rangeEfficacy: The percentage of patients in whom the SBP falls below the lower limit of the pre-specified target range at any time Efficacy: The percentage of patients in whom the SBP falls below the lower limit of the pre-specified target range at any time during the entire study drug treatment period Efficacy: The percentage of patients in whom the SBP is within target range at each hour after the first 30 minutes of clevidipine infusion Efficacy: The percentage of patients who require rescue therapy (i.e. receive any alternative IV antihypertensive drug) at any time during the study drug treatment period Efficacy: Percent change in SBP from baseline at each time point Efficacy: Percent change from baseline in SBP Efficacy: Percent change from baseline in SBP over the first 8 hours post-study drug termination Efficacy: Percent change from baseline in heart rate Efficacy: Percent change from baseline in heart rate
Detailed description:
This is an open label study to assess, in a stepwise approach across 4 age cohorts from
oldest to youngest (birth to
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
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 patient 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
- Patient 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
- Patients who, for any reason, are deemed by the Investigator to be inappropriate for
this study
- Subject 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
Locations and Contacts
Hassan Danesi, MD, Phone: 973-290-6173, Email: hassan.danesi@themedco.com
Stanford Medical Center, Stanford, California 94305, United States; Recruiting Carol Cohane, RN, Phone: 650-736-8231, Email: cohane@stanford.edu
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting Julie Rice, RN,BSN,CCRC, Phone: 614-355-3142, Email: Julie.rice@nationwidechilrens.org
Additional Information
Starting date: March 2014
Last updated: August 21, 2014
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