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RECRUITING
NCT02323399
PHASE4

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

Sponsor: West-Ward Pharmaceutical

View on ClinicalTrials.gov

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

DRUG

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