RecruitingPhase 4NCT02323399

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

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

Sponsor

West-Ward Pharmaceutical

Enrollment

100 participants

Start Date

Feb 1, 2015

Study Type

INTERVENTIONAL

Conditions

Hypotension

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.

Eligibility

Min Age: 12 YearsMax Age: 16 Years

Inclusion Criteria6

Subject's age is between ≥12 and 16 years, inclusive
Subject is scheduled for a procedure that requires general or neuraxial anesthesia
Subjects must have normal or clinically acceptable physical exam
Subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
Subject's parent or legal guardian gives informed consent and subject gives assent.

Exclusion Criteria8

Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody
Subjects taking antihypertensive medication
Subject is moribund (death is likely to occur in less than 48 hours)
Females who are pregnant, nursing or unwilling to use/practice adequate contraception.

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Interventions

DRUGPhenylephrine

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.