Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01151085
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.
- Subject who heve been prescribed voriconazole (VFEND) before.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) | |||
| Official Title | Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan) | |||
| Brief Summary | To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice. | |||
| Detailed Description | 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND). | |||
| Condition | Systemic Mycosis | |||
| Intervention | 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 | |||
| Study Groups/Cohorts | Voriconazole
Subjects who are treated with voriconazole Intervention: Drug: Voriconazole | |||
| 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 | 1002 | |||
| Original Estimated Enrollment | 1100 | |||
| Actual Study Completion Date | May 2012 | |||
| Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | NCT01151085 | |||
| Other Study ID Numbers | A1501076 | |||
| 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 |
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| PRS Account | Pfizer | |||
| Verification Date | May 2013 | |||