Precedex Special Investigation (in Pediatric Patients)
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|ClinicalTrials.gov Identifier: NCT04040439|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment|
|Sedation||Drug: Dexmedetomidine Hydrochloride|
To assess the data, including safety profile, of Precedex Intravenous Solution administered for "sedation during and after mechanical ventilation in the intensive care setting" in pediatric patients under actual medical practice in Japan.
Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Precedex Intravenous Solution Special Investigation (in Pediatric Patients)|
|Estimated Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||April 8, 2022|
|Estimated Study Completion Date :||April 8, 2022|
Pediatric patients (45 weeks corrected gestational age to <18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation during and after mechanical ventilation in the intensive care setting"
Drug: Dexmedetomidine Hydrochloride
[Sedation during and after mechanical ventilation in the intensive care setting] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition.
For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate.
Other Name: Precedex
- Number of participants with adverse drug reactions (ADRs) [ Time Frame: From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU)(up to Month 33, at the longest) ]Regarding Time Frame, if a participant leaves the ICU before 24 hours after the end of administration of Precedex, adverse events (AEs) observed up to 24 hours after the end of administration should be entered in the case report form (CRF) as much as possible, and the AEs should be monitored until the outcomes become known as far as possible.
- Percentage of participants who are evaluated as effective (responders) by the investigator [ Time Frame: At the end of administration of Precedex (up to Month 33, at the longest) ]Effectiveness evaluation (effective, not effective, or indeterminate) of Precedex will be performed by investigators at the end of administration of this drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040439
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Pfizer Japan Local Country Office||Not yet recruiting|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|