N/A
Completed N=111
Precedex Special Investigation (in Pediatric Patients)
Source: ClinicalTrials.gov NCT04040439 ↗Enrolled (actual)
111
Serious AEs
4.1%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions — 9; 2 Participants
Summary
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
9; 2 | — |
| SECONDARY Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician |
100.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Pediatric patients (45 weeks corrected gestational age to <18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting.
Exclusion Criteria
- No exclusion criteria is set out in this study.
Data sourced from ClinicalTrials.gov (NCT04040439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.