RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2015-02
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02323399

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.

Ages Eligible for Study:12 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Subject's age is between ≥12 and 16 years, inclusive
  2. 2. Subject is scheduled for a procedure that requires general or neuraxial anesthesia
  3. 3. Subjects must have normal or clinically acceptable physical exam
  4. 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. 5. Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
  6. 6. Subject's parent or legal guardian gives informed consent and subject gives assent.
  1. 1. Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
  2. 2. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
  3. 3. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
  4. 4. Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
  5. 5. Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
  6. 6. Subjects taking antihypertensive medication
  7. 7. Subject is moribund (death is likely to occur in less than 48 hours)
  8. 8. Females who are pregnant, nursing or unwilling to use/practice adequate contraception.

Contacts and Locations

Study Contact

J. Barton Kalis
CONTACT
856-489-2247
jkalis@hikma.com

Principal Investigator

Cesar Ormeno, MD
STUDY_DIRECTOR
PRA Health Sciences

Study Locations (Sites)

Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Jackson Memorial Hospital
Miami, Florida, 33136-1005
United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322-1062
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39126
United States
Stony Brook Medicine
Stony Brook, New York, 11794
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Children's Medical Center of Dallas
Dallas, Texas, 75390
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Ruby Memorial Hospital
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: West-Ward Pharmaceutical

  • Cesar Ormeno, MD, STUDY_DIRECTOR, PRA Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-02
Study Completion Date2024-12

Study Record Updates

Study Start Date2015-02
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Hypotension