Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
NCT01073631
Last updated date
ABOUT THIS STUDY
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the
Korean government agency.
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
Eligibility Criteria
condition
Serious Fungal Infections
Sex
Females and Males
Age
0 +
Inclusion Criteria
Show details
- Patients who are indicated for voriconazole table according to the drug package insert.
Exclusion Criteria
Show details
- None.
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Advanced Information
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 | 543 | |||
Original Actual Enrollment | 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:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2012 |