Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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.