Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Sponsor: West-Ward Pharmaceutical
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.
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
Key Details
Gender
All
Age Range
12 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2015-02
Completion Date
2024-12
Last Updated
2024-07-23
Healthy Volunteers
Yes
Conditions
Interventions
Phenylephrine
one of six initial treatments Phenylephrine Hydrochloride Injection (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 PK sampling schedules.
Locations (10)
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Jackson Memorial Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Stony Brook Medicine
Stony Brook, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Ruby Memorial Hospital
Morgantown, West Virginia, United States