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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2014-04-02 |
| Est. Completion | 2017-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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