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

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02323399
• Other study ID #: 1420RDP009
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: West-Ward Pharmaceutical
• Contact: J. Barton Kalis
• Phone: 856-489-2247
• Email: jkalis[@]hikma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 4 multi-center, randomized open-label study in 100 subjects aged ≥12 to 16 years who experience a decrease in blood pressure during a procedure requiring general or neuraxial anesthesia. At least 300 subjects will be enrolled in this study. It is anticipated that up to 33% of enrolled subjects will actually experience a decrease in blood pressure that requires treatment and so will receive Phenylephrine Hydrochloride Injection (PHI). There are 12 possible randomization assignments: one of six initial treatments 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 pharmacokinetics (PK) sampling schedules.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Subject's age is between =12 and 16 years, inclusive

2. Subject is scheduled for a procedure that requires general or neuraxial anesthesia

3. Subjects must have normal or clinically acceptable physical exam

4. 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)

5. Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1

6. Subject's parent or legal guardian gives informed consent and subject gives assent.

Exclusion Criteria:

1. Subject has a contraindication to vasoconstrictor therapy for control of blood pressure

2. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment

3. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures

4. Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration

5. Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody

6. Subjects taking antihypertensive medication

7. Subject is moribund (death is likely to occur in less than 48 hours)

8. Females who are pregnant, nursing or unwilling to use/practice adequate contraception.

Related Conditions & MeSH terms

• Hypotension

Intervention

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

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Jackson Memorial Hospital	Miami	Florida
United States	Ruby Memorial Hospital	Morgantown	West Virginia
United States	Seattle Children's Hospital	Seattle	Washington
United States	Stony Brook Medicine	Stony Brook	New York
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I. DuPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
West-Ward Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Phenylephrine (PE) concentrations will be measured using a validated liquid chromatography/mass spectrometry (LCMS/MS) assay.		Screening up to Day 3