Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
NCT02323399 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Phenylephrine
Study Locations (10)
Delaware
- Alfred I. DuPont Hospital for Children — Wilmington
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- Jackson Memorial Hospital — Miami
Georgia
- Children's Healthcare of Atlanta at Egleston — Atlanta
Mississippi
- University of Mississippi Medical Center — Jackson
New York
- Stony Brook Medicine — Stony Brook
Ohio
- Cleveland Clinic — Cleveland
Texas
- Children's Medical Center of Dallas — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-02 |
| Est. Completion | 2024-12 |
| Phase | Phase 4 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02323399
The ClinicalTrials.gov registry entry for NCT02323399 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is West-Ward Pharmaceutical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hypotension appearing as the primary indexed condition, and to 1 intervention — of which Phenylephrine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02323399 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Delaware, District of Columbia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02323399 about?
NCT02323399 is a clinical study titled "Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV". 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...
What is the current status of trial NCT02323399?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2015-02. Estimated completion is 2024-12.
What conditions does trial NCT02323399 study?
This clinical trial studies the following conditions: Hypotension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02323399?
The interventions under investigation include: Phenylephrine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02323399?
This trial is sponsored by West-Ward Pharmaceutical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02323399 being conducted?
This trial has 10 study locations across Delaware, District of Columbia, Florida, Georgia, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.