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Precedex Special Investigation (in Pediatric Patients)

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Pfizer

Status

Completed

Conditions

Sedation

Treatments

Drug: Dexmedetomidine Hydrochloride

Study type

Observational

Funder types

Industry

Identifiers

NCT04040439
C0801023

Details and patient eligibility

About

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

Full 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.

Enrollment

111 patients

Sex

All

Ages

45 weeks to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

111 participants in 1 patient group

Dexmedetomidine Hydrochloride
Description:
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"
Treatment:
Drug: Dexmedetomidine Hydrochloride

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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