Back to resultsStudy to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Primary Purpose
Hypotension
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Alfred I. DuPont Hospital for Children
- Children's National Medical Center
- Jackson Memorial HospitalRecruiting
- Children's Healthcare of Atlanta at Egleston
- University of Mississippi Medical Center
- Stony Brook Medicine
- Cleveland ClinicRecruiting
- Children's Medical Center of DallasRecruiting
- Seattle Children's Hospital
- Ruby Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phenylephrine
Arm Description
Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim
Outcomes
Primary Outcome Measures
Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay.
Secondary Outcome Measures
Full Information
NCT ID
NCT02323399
First Posted
December 17, 2014
Last Updated
July 11, 2023
Sponsor
West-Ward Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT02323399
Brief Title
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West-Ward Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a Phase 4 multi-center, randomized open-label study in 100 subjects aged ≥12 to 16 years who experience a decrease in blood pressure during a procedure requiring general or neuraxial anesthesia. At least 300 subjects will be enrolled in this study. It is anticipated that up to 33% of enrolled subjects will actually experience a decrease in blood pressure that requires treatment and so will receive Phenylephrine Hydrochloride Injection (PHI). There are 12 possible randomization assignments: one of six initial treatments 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 pharmacokinetics (PK) sampling schedules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phenylephrine
Arm Type
Experimental
Arm Description
Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Phenylephrine Hydrochloride Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay.
Time Frame
Screening up to Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J. Barton Kalis
Phone
856-489-2247
Email
jkalis@hikma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Ormeno, MD
Organizational Affiliation
PRA Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Alfred I. DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Terminated
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Barton Kalis
Phone
856-489-2247
Email
jkalis@hikma.com
Facility Name
Children's Healthcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1062
Country
United States
Individual Site Status
Terminated
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39126
Country
United States
Individual Site Status
Terminated
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Terminated
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Barton Kalis
Phone
856-489-2247
Email
jkalis@hikma.com
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.Barton Kalis
Phone
856-489-2247
Email
jkalis@hikma.com
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Terminated
12. IPD Sharing Statement
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Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
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