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Study identifier: NCT02323399 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Hypotension  ·  Sponsor: West-Ward Pharmaceutical

PhasePhase 4
Planned participants100
Who can joinAll sexes, 12 Years to 16 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

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

Always discuss trial participation with your own doctor first.

Locations (10)

Alfred I. DuPont Hospital for ChildrenWilmington, Delaware, United StatesWithdrawn
Children's National Medical CenterWashington D.C., District of Columbia, United StatesTerminated
Jackson Memorial HospitalMiami, Florida, United StatesRecruiting
Children's Healthcare of Atlanta at EglestonAtlanta, Georgia, United StatesTerminated
University of Mississippi Medical CenterJackson, Mississippi, United StatesTerminated
Stony Brook MedicineStony Brook, New York, United StatesTerminated
Cleveland ClinicCleveland, Ohio, United StatesRecruiting
Children's Medical Center of DallasDallas, Texas, United StatesRecruiting
Seattle Children's HospitalSeattle, Washington, United StatesWithdrawn
Ruby Memorial HospitalMorgantown, West Virginia, United StatesTerminated

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Source record: clinicaltrials.gov/study/NCT02323399