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Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV

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ClinicalTrials.gov Identifier: NCT02323399
Recruitment Status : Unknown
Verified September 2020 by West-Ward Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : December 23, 2014
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypotension Drug: Phenylephrine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phenylephrine
Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim
 Drug: Phenylephrine
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.
Other Name: Phenylephrine Hydrochloride Injection


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay. [ Time Frame: Screening up to Day 3 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject's age is between ≥12 and 16 years, inclusive
  2. Subject is scheduled for a procedure that requires general or neuraxial anesthesia
  3. Subjects must have normal or clinically acceptable physical exam
  4. 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)
  5. Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
  6. Subject's parent or legal guardian gives informed consent and subject gives assent.

Exclusion Criteria:

  1. Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
  2. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
  3. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
  4. Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
  5. Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
  6. Subjects taking antihypertensive medication
  7. Subject is moribund (death is likely to occur in less than 48 hours)
  8. Females who are pregnant, nursing or unwilling to use/practice adequate contraception.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323399


Contacts
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Contact: J. Barton Kalis 856-489-2247 jkalis@hikma.com

Locations
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United States, Delaware
Alfred I. DuPont Hospital for Children Withdrawn
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Terminated
Washington, District of Columbia, United States, 20010
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136-1005
Contact: J. Barton Kalis    856-489-2247    jkalis@hikma.com   
United States, Georgia
Children's Healthcare of Atlanta at Egleston Terminated
Atlanta, Georgia, United States, 30322-1062
United States, Mississippi
University of Mississippi Medical Center Terminated
Jackson, Mississippi, United States, 39126
United States, New York
Stony Brook Medicine Terminated
Stony Brook, New York, United States, 11794
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: J. Barton Kalis    856-489-2247    jkalis@hikma.com   
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: J.Barton Kalis    856-489-2247    jkalis@hikma.com   
United States, Washington
Seattle Children's Hospital Withdrawn
Seattle, Washington, United States, 98105
United States, West Virginia
Ruby Memorial Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: J. Barton Kalis    856-489-2247    jkalis@hikma.com   
Sponsors and Collaborators
West-Ward Pharmaceutical
Investigators
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Study Director: Cesar Ormeno, MD PRA Health Sciences
More Information
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Responsible Party: West-Ward Pharmaceutical
ClinicalTrials.gov Identifier: NCT02323399    
Other Study ID Numbers: 1420RDP009
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: September 2020
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
 Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents