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Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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NCT01151085

Last updated on April 11, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Mycosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female subjects intend to treat their deep mycosis who are prescribed
voriconazole (VFEND) by their Physicians.

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

- Subject who heve been prescribed voriconazole (VFEND) before.

NCT01151085
Pfizer
Completed
Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).
Systemic Mycosis
Drug: Voriconazole

Voriconazole Intravenous Solution 200 mg:

Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.

Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:

administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.

Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.

However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.

In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.

Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.

Other Name: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet
Voriconazole
Subjects who are treated with voriconazole
Intervention: Drug: Voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1002
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.

Exclusion Criteria:

  • Subject who heve been prescribed voriconazole (VFEND) before.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01151085
A1501076
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

FOR MORE INFORMATION

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