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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Serious Fungal InfectionsNon-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
NCT01073631
ALL GENDERS
0+
years
MULTIPLE SITES
Serious Fungal InfectionsNon-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
NCT01073618
ALL GENDERS
0+
years
MULTIPLE SITES
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 | |||