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
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
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
- 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 | |||