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

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Hypotension
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.

Trial Locations (10)

11794

TERMINATED

Stony Brook Medicine, Stony Brook

19803

WITHDRAWN

Alfred I. DuPont Hospital for Children, Wilmington

20010

TERMINATED

Children's National Medical Center, Washington D.C.

26506

TERMINATED

Ruby Memorial Hospital, Morgantown

39126

TERMINATED

University of Mississippi Medical Center, Jackson

44195

RECRUITING

Cleveland Clinic, Cleveland

75390

RECRUITING

Children's Medical Center of Dallas, Dallas

98105

WITHDRAWN

Seattle Children's Hospital, Seattle

33136-1005

RECRUITING

Jackson Memorial Hospital, Miami

30322-1062

TERMINATED

Children's Healthcare of Atlanta at Egleston, Atlanta

All Listed Sponsors
lead

West-Ward Pharmaceutical

INDUSTRY