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

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
West-Ward Pharmaceutical
Study ID
NCT02323399
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Hypotension

Eligibility Criteria

Sex
ALL
Age
12 Years - 16 Years
Healthy Volunteers
Accepted

Interventions

  • Phenylephrine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2015
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phenylephrine
    Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim

Primary Outcome Measure

Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay. [ Time Frame: Screening up to Day 3 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Alfred I. DuPont Hospital for ChildrenWilmingtonDelaware19803-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Jackson Memorial HospitalMiamiFlorida33136-1005
J. Barton Kalis
[email protected]
856-489-2247
Children's Healthcare of Atlanta at EglestonAtlantaGeorgia30322-1062-
University of Mississippi Medical CenterJacksonMississippi39126-
Stony Brook MedicineStony BrookNew York11794-
Cleveland ClinicClevelandOhio44195
J. Barton Kalis
[email protected]
856-489-2247
Children's Medical Center of DallasDallasTexas75390
J.Barton Kalis
[email protected]
856-489-2247
Seattle Children's HospitalSeattleWashington98105-
Ruby Memorial HospitalMorgantownWest Virginia26506-

Find similar trials in Wilmington, DE

By research site
Alfred I. DuPont Hospital for Children· Wilmington, DEChildren's National Medical Center· Washington D.C., DCJackson Memorial Hospital· Miami, FLChildren's Healthcare of Atlanta at Egleston· Atlanta, GAUniversity of Mississippi Medical Center· Jackson, MSStony Brook Medicine· Stony Brook, NY

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