Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01915277 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

A Phase 1 study, sponsored by Carelon Research.

Completed
Registry status
Phase 1
Development phase
119
Enrollment target

NCT01915277 is a Phase 1 study that has completed, run by Carelon Research. The registered enrollment target is 119 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01915277, a Phase 1 study, has completed, sponsored by Carelon Research.

COMPLETED
Registry status
Phase 1
Development phase
119 participants
Enrollment target

Study Summary

The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. This study will also design and validate a dosing schema for the use of DEX as described above.

Interventions

  • DRUG Dexmedetomidine

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2014-04-02
Est. Completion 2017-10-17
Phase Phase 1

Sponsor

Carelon Research

50 total trials

What the Registry Record Tells You About NCT01915277

The ClinicalTrials.gov registry entry for NCT01915277 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.

NCT01915277 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01915277 about?

NCT01915277 is a clinical study titled "A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics". The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac pro...

What is the current status of trial NCT01915277?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2014-04-02. Estimated completion is 2017-10-17.

What interventions are being tested in trial NCT01915277?

The interventions under investigation include: Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT01915277?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.