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

Recruiting Phase 4 Interventional Study
Hypotension
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
12 – 16
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
West-Ward Pharmaceutical · Industry
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About This Trial
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, an…
Trial Locations
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Eligibility Criteria
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 …
Contacts

J. Barton Kalis

856-489-2247

jkalis@hikma.com

CONTACT