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A Phase 4 Multi-center, Ascending Dose, Open Label Study to Determine the Pharmacokinetics of Phenylephrine and the Pharmacodynamic Effects on Blood Pressure following Intravenous Administration of Phenylephrine Hydrochloride Injection, USP in Pediatric Subjects (≥12 to 16 years of age) Undergoing General and Neuroaxial Anesthesia
Study ID: STU 082014-004
Study subjects will be scheduled for procedures requiring general or neuroaxial anesthesia. Subjects will be non-shock, non-trauma patients, with no history of Tetralogy of Fallot. in order to be treated, subjects must experience a decrease in BP during the procedure that requires drug intervention. PHi will be administered to six successive cohorts with 16 to 17 subjects in each cohort. The first three successive cohorts (1, 2, and 3) will receive infusion treatments. after the infusion is initiated, a minimum infusion time of 10 minutes (approximately 2 to 3 times the distribution half-life, approaching steady state) will permit meaningful assessments of safety and pharmacodynamic responses. The second three successive cohorts (4, 5, and 6) will receive bolus treatments. according to the approved labeling for adults, the onset of BP increase following administration of a bolus dose is rapid. in this study, a minimum time interval of 2 minutes will be allowed in order to assess response before further doses are administered. Safety assessments include adverse events (aes) and laboratory test results. Safety will be evaluated by the Cohort Review Committee (CRC) after each dosing level cohort completes the study, and approval will be granted for the next cohort to begin treatment at a higher dose. Following completion of Cohort 3, the highest dosing level for infusion treatment, the Data Safety Monitoring Board (DSMB) will review both safety data and PK data before approving treatment with bolus doses. The proposed bolus doses will be reviewed in order to assure that the projected Cmax values will be lower than the Cmax for the completed infusion cohorts.
1. Subject[Single Quote]s age is between 12 and 16 years, inclusive 2. Subject is scheduled for a procedure that requires general or neuroaxial 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 minute of rest) 5. Females of child-bearing potential must have a negative serum pregnancy test (Human Chorionic Gonadotropin) at Baseline and negative urine pregnancy test on Day 1 (urine pregnancy test not required if Visits 1 and 2 are on the same day but results of the serum pregnancy test must be reported before the procedure) 6. Subject[Single Quote]s parent or legal guardian gives informed consent and subject gives assent.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- PETER SZMUK
The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride injection, uSP on the treatment of clinically relevant decreased blood pressure in the pediatric population, [GreaterThanorequalTo]12 to 16 year old patients undergoing general and neuroaxial anesthesia. The secondary objectives are to describe changes in blood pressure and heart rate, the 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.