Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
Public ClinicalTrials.gov record NCT02323399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02323399
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2015
- Primary completion
- Nov 30, 2024
- Completion
- Nov 30, 2024
- Last update posted
- Jul 22, 2024
2015 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alfred I. DuPont Hospital for Children | Wilmington | Delaware | 19803 | Withdrawn |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | Terminated |
| Jackson Memorial Hospital | Miami | Florida | 33136-1005 | Recruiting |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322-1062 | Terminated |
| University of Mississippi Medical Center | Jackson | Mississippi | 39126 | Terminated |
| Stony Brook Medicine | Stony Brook | New York | 11794 | Terminated |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Children's Medical Center of Dallas | Dallas | Texas | 75390 | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Withdrawn |
| Ruby Memorial Hospital | Morgantown | West Virginia | 26506 | Terminated |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02323399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02323399 live on ClinicalTrials.gov.