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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
Sponsor:
Information provided by:
Pfizer

September 12, 2005
September 15, 2005
May 10, 2011
June 2003
Not Provided
The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.
Same as current
Complete list of historical versions of study NCT00174473 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
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.
This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neutropenia
Drug: Voriconazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
36
August 2005
Not Provided

Inclusion Criteria:

  • Children who require a systemic antifungal agent for the prevention of systemic fungal infection

Exclusion Criteria:

  • Children who are receiving medications which cannot be taken concomitantly with voriconazole.
Sexes Eligible for Study: All
2 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00174473
A1501037
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP