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Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

Last updated on January 19, 2020

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Serious Fungal Infections
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

- Patients who are indicated for voriconazole table according to the drug package
insert.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT01073631
Pfizer
Completed
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

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Descriptive Information
Brief Title Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
Official Title Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet
Brief Summary This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are indicated for voriconazole tablet according to the drug package insert.
Condition Serious Fungal Infections
Intervention Drug: voriconazole tablet
200 mg PO bid (orally, twice a day)
Other Name: Vfend
Study Groups/Cohorts 1
Patients who are indicated for use of voriconazole tablet.
Intervention: Drug: voriconazole tablet
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 Status Completed
Actual Enrollment
 (submitted: July 13, 2010)
543
Original Actual Enrollment
 (submitted: February 22, 2010)
547
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who are indicated for voriconazole table according to the drug package insert.

Exclusion Criteria:

  • None.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01073631
Other Study ID Numbers A1501068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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