Actively Recruiting
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Led by West-Ward Pharmaceutical · Updated on 2024-07-23
100
Participants Needed
10
Research Sites
513 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject's age is between 6512 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 must have mean systolic/diastolic office blood pressure 64128/78 mmHg (sitting, after 5 minutes rest)
- Females must have a negative urine or serum pregnancy test at Screening and Day 1
- Subject's parent or legal guardian gives informed consent and subject gives assent
You will not qualify if you...
- Subject has a contraindication to vasoconstrictor therapy for blood pressure control
- Subject participated in other investigational drug/device clinical trials within 30 days before enrollment
- Subject has any serious medical condition likely to interfere with study procedures
- Subjects have had any clinically significant local or systemic infectious disease within 4 weeks prior to treatment
- Subjects positive for hepatitis B surface antigen or hepatitis C antibody
- Subjects taking antihypertensive medication
- Subject is moribund with expected death within 48 hours
- Females who are pregnant, nursing, or unwilling to use adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
Withdrawn
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Terminated
3
Jackson Memorial Hospital
Miami, Florida, United States, 33136-1005
Actively Recruiting
4
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322-1062
Terminated
5
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39126
Terminated
6
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Terminated
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Children's Medical Center of Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
9
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Withdrawn
10
Ruby Memorial Hospital
Morgantown, West Virginia, United States, 26506
Terminated
Research Team
J
J. Barton Kalis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here