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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 range

Efficacy: 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

Page last updated: August 23, 2015

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