A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
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|ClinicalTrials.gov Identifier: NCT00174473|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Neutropenia||Drug: Voriconazole||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Intravenous to Oral Switch, Multiple Dose Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infections.|
|Study Start Date :||June 2003|
|Actual Study Completion Date :||August 2005|
- The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.
- The secondary objective was to evaluate the safety and tolerability of multiple dose administration of voriconazole in immunocompromised children requiring treatment for the prevention of systemic fungal infection.
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): NCT00174473
|Study Director:||Pfizer CT.gov Call Center||Pfizer|