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Precedex Special Investigation (in Pediatric Patients)

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Japan Local Country Office
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sedation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + weeks
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pediatric patients (45 weeks corrected gestational age to this drug for "sedation during and after mechanical ventilation in the intensive care
setting.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- No exclusion criteria is set out in this study.

NCT04040439
Pfizer
Active, not recruiting
Precedex Special Investigation (in Pediatric Patients)

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Descriptive Information
Brief TitlePrecedex Special Investigation (in Pediatric Patients)
Official TitlePrecedex Intravenous Injections Special Investigation (Pediatric)
Brief SummarySecondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
Detailed Description

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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPediatric 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"
ConditionSedation
InterventionDrug: 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 ?g/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 ?g/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 ?g/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 ?g/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
Study Groups/CohortsDexmedetomidine Hydrochloride
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"
Intervention: Drug: Dexmedetomidine Hydrochloride
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusActive, not recruiting
Estimated Enrollment
 (submitted: September 23, 2019)
110
Original Estimated Enrollment
 (submitted: July 29, 2019)
100
Estimated Study Completion DateApril 8, 2022
Estimated Primary Completion DateApril 8, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages45 Weeks to 17 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT04040439
Other Study ID NumbersC0801023
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsMaruishi Pharmaceutical
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

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