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

NCT01073618

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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

- Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- N/A

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Advanced Information
Descriptive Information
Brief Title Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Official Title Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Brief Summary This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
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 VFEND according to drug package insert.
Condition Serious Fungal Infections
Intervention Drug: voriconazole IV
6 mg/kg iv q 12 hours (loading) then maintenance
Other Name: Vfend
Study Groups/Cohorts A.
Patients who are indicated for VFEND according to drug package insert.
Intervention: Drug: voriconazole IV
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 15, 2010)
692
Original Actual Enrollment
 (submitted: February 22, 2010)
696
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria:

  • N/A
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 NCT01073618
Other Study ID Numbers A1501067
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 CenterPfizer
PRS Account Pfizer
Verification Date May 2012