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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - 16
Updated:12/5/2018
Start Date:February 2015
End Date:June 2022
Contact:J. Barton Kalis
Email:jkalis@hikma.com
Phone:856-489-2247

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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

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.

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.

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.
We found this trial at
10
sites
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 856-489-2247
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 856-489-2247
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Phone: 856-489-2247
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Phone: 856-489-2247
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Miami, FL
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Wilmington, DE
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Atlanta, Georgia 30322
Phone: 856-489-2247
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Atlanta, GA
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Phone: 856-489-2247
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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Morgantown, West Virginia 26506
Phone: 856-489-2247
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Morgantown, WV
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Stony Brook, New York 11794
Phone: 856-489-2247
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Stony Brook, NY
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Phone: 856-489-2247
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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