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NCT02323399 · ClinicalTrials.gov registry record · Phase 4
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
A Phase 4 study of Hypotension, sponsored by West-Ward Pharmaceutical.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 10
- Study locations
NCT02323399 is a Phase 4 study of Hypotension that is actively recruiting participants, run by West-Ward Pharmaceutical. The registered enrollment target is 100 participants, above the 72-participant average among 12 other Hypotension trials with a reported enrollment target (39% higher). The trial reports 10 study locations across 10 states.
The verdict
NCT02323399, a Phase 4 study of Hypotension, is actively recruiting participants, sponsored by West-Ward Pharmaceutical.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 10
- Study locations
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?
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, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 72-participant average among 12 other Hypotension trials with a reported enrollment target (39% higher). The listed sponsor is West-Ward Pharmaceutical, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT02323399 reports 10 study locations spanning 10 distinct geographic areas - top geographies include Delaware, District of Columbia, Florida.
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.
What interventions are being tested in trial NCT02323399?
The interventions under investigation include: Phenylephrine (DRUG).
Who is sponsoring clinical trial NCT02323399?
This trial is sponsored by West-Ward Pharmaceutical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.