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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: Recruiting Phase 4 study of Hypotension, sponsored by West-Ward Pharmaceutical.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2015-02
Est. Completion 2024-12
Phase Phase 4
West-Ward Pharmaceutical

4 total trials

What NCT02323399 shows while recruiting

NCT02323399 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 72-participant average among 12 other Hypotension trials with a reported enrollment target (39% higher).

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 lists 10 locations in 10 states (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.

Similar trials for Hypotension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02323399's enrollment target sits among peer trials

100 4th of 12 higher than 9 of 12 other Hypotension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypotension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02323399, the US trial registry maintained by the National Library of Medicine. NCT02323399 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.