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

  • STATUS
    Recruiting
  • End date
    Jun 27, 2022
  • participants needed
    100
  • sponsor
    West-Ward Pharmaceutical
Updated on 27 September 2020
Investigator
J. Barton Kalis
Primary Contact
Children's National Medical Center (5.4 mi away) Contact
+9 other location
diabetes
anesthesia

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.

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 g/kg), Med (3 g/kg), or High (5 g/kg) level; PHI will be initially administered to approximately 50 subjects as a continuous intravenous infusion (IV-I) at Low (0.25 g/kg/min), Med (0.75 g/kg/min), or High (1.25 g/kg/min) level]; each initial treatment group will have two pharmacokinetics (PK) sampling schedules.

Details
Treatment Phenylephrine
Clinical Study IdentifierNCT02323399
SponsorWest-Ward Pharmaceutical
Last Modified on27 September 2020

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Eligibility

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Inclusion Criteria

Is your age between 12 yrs and 16 yrs?
Gender: Male or Female
Do you have any of these conditions: Hypotension or Low Blood Pressure (Hypotension) or Vascular Diseases?
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
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