Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
NCT ID: NCT02323399
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2015-02-28
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phenylephrine
Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
16 Years
ALL
Yes
Sponsors
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West-Ward Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Cesar Ormeno, MD
Role: STUDY_DIRECTOR
PRA Health Sciences
Locations
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Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Jackson Memorial Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Stony Brook Medicine
Stony Brook, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Ruby Memorial Hospital
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1420RDP009
Identifier Type: -
Identifier Source: org_study_id
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