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

Description

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.

Conditions

Hypotension

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Study Overview

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Study Details

Study overview

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.

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

Condition
Hypotension
Intervention / Treatment

-

Contacts and Locations

Wilmington

Alfred I. DuPont Hospital for Children, Wilmington, Delaware, United States, 19803

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Miami

Jackson Memorial Hospital, Miami, Florida, United States, 33136-1005

Atlanta

Children's Healthcare of Atlanta at Egleston, Atlanta, Georgia, United States, 30322-1062

Jackson

University of Mississippi Medical Center, Jackson, Mississippi, United States, 39126

Stony Brook

Stony Brook Medicine, Stony Brook, New York, United States, 11794

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Dallas

Children's Medical Center of Dallas, Dallas, Texas, United States, 75390

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Morgantown

Ruby Memorial Hospital, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

12 Years to 16 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

West-Ward Pharmaceutical,

Cesar Ormeno, MD, STUDY_DIRECTOR, PRA Health Sciences

Study Record Dates

2024-12