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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01073631
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : September 13, 2010
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.

Condition or disease Intervention/treatment
Serious Fungal Infections Drug: voriconazole tablet

Study Design
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Study Type : Observational
Actual Enrollment : 543 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet
Study Start Date : March 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Patients who are indicated for use of voriconazole tablet.
 Drug: voriconazole tablet
200 mg PO bid (orally, twice a day)
Other Name: Vfend


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable [ Time Frame: Baseline (Day 1) up to 2.1 Years ]
    Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).


Secondary Outcome Measures :
  1. Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable [ Time Frame: Baseline (Day 1) up to 2.1 Years ]
    In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are indicated for voriconazole tablet according to the drug package insert.
Criteria

Inclusion Criteria:

  • Patients who are indicated for voriconazole table according to the drug package insert.

Exclusion Criteria:

  • None.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073631


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01073631    
Other Study ID Numbers: A1501068
First Posted: February 23, 2010    Key Record Dates
Results First Posted: September 13, 2010
Last Update Posted: June 7, 2012
Last Verified: May 2012
Keywords provided by Pfizer:
voriconazole
Korea
invasive fungal infection
Additional relevant MeSH terms:
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Mycoses
Infections
Bacterial Infections and Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors