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

Last updated: July 22, 2024
Sponsor: West-Ward Pharmaceutical
Overall Status: Active - Recruiting

Phase

4

Condition

Dizzy/fainting Spells

Vascular Diseases

Circulation Disorders

Treatment

Phenylephrine

Clinical Study ID

NCT02323399
1420RDP009
  • Ages 12-16
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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/diastolicoffice 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

Exclusion Criteria:

  1. Subject has a contraindication to vasoconstrictor therapy for control of bloodpressure

  2. Subject has participated in other clinical trials for investigational drugs and/ordevices 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 systemicinfectious 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 adequatecontraception.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Phenylephrine
Phase: 4
Study Start date:
February 01, 2015
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Alfred I. DuPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Terminated

  • Children's National Medical Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Jackson Memorial Hospital

    Miami, Florida 33136-1005
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta at Egleston

    Atlanta, Georgia 30322-1062
    United States

    Terminated

  • University of Mississippi Medical Center

    Jackson, Mississippi 39126
    United States

    Terminated

  • Stony Brook Medicine

    Stony Brook, New York 11794
    United States

    Terminated

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Children's Medical Center of Dallas

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Ruby Memorial Hospital

    Morgantown, West Virginia 26506
    United States

    Terminated

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