Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Phase 4 Open Label Study to Determine Pharmacokinetics of Phenylephrine and Pharmacodynamic Effects on BP Via IV Admin of Phenylephrine Hydrochloride Inj in Ped Subjects (≥12 to 16 Years of Age) Undergoing Gen and Neuraxial Anesthesia
1 other identifier
interventional
100
1 country
10
Brief Summary
The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia. The secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2015
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 23, 2024
July 1, 2024
9.8 years
December 17, 2014
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay.
Screening up to Day 3
Study Arms (1)
Phenylephrine
EXPERIMENTALPhenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim
Interventions
one of six initial treatments Phenylephrine Hydrochloride Injection (PHI) will be initially administered to approximately 50 subjects as an intravenous bolus (IV-B) at Low (1 μg/kg), Med (3 μg/kg), or High (5 μg/kg) level; PHI will be initially administered to approximately 50 subjects as a continuous intravenous infusion (IV-I) at Low (0.25 μg/kg/min), Med (0.75 μg/kg/min), or High (1.25 μg/kg/min) level\]; each initial treatment group will have two PK sampling schedules.
Eligibility Criteria
You may qualify if:
- Subject's age is between ≥12 and 16 years, inclusive
- Subject is scheduled for a procedure that requires general or neuraxial anesthesia
- Subjects must have normal or clinically acceptable physical exam
- Subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
- Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
- Subject's parent or legal guardian gives informed consent and subject gives assent.
You may not qualify if:
- Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
- Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
- Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
- Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
- Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
- Subjects taking antihypertensive medication
- Subject is moribund (death is likely to occur in less than 48 hours)
- Females who are pregnant, nursing or unwilling to use/practice adequate contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Jackson Memorial Hospital
Miami, Florida, 33136-1005, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322-1062, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39126, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Children's Medical Center of Dallas
Dallas, Texas, 75390, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cesar Ormeno, MD
PRA Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2014
First Posted
December 23, 2014
Study Start
February 1, 2015
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
July 23, 2024
Record last verified: 2024-07