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The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Versicor, Inc.
King of Prussia, Pennsylvania, 19406 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Positive culture plus at least one clinical sign and symptom consistent with invasive
candidiasis preferably within 96 hours of the proposed first dose of study drug

- Life expectancy: greater than 72 hours

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

- Pregnant Females

- Treatment with other investigational drug(s) within 4 weeks

- Hypersensitivity to anidulafungin or echinocandin therapy

- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

NCT00037219
Pfizer
Completed
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

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The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis
Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Candidiasis
Drug: Anidulafungin, VER002
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2002
Not Provided

Inclusion Criteria:

  • Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
  • Life expectancy: greater than 72 hours

Exclusion Criteria:

  • Pregnant Females
  • Treatment with other investigational drug(s) within 4 weeks
  • Hypersensitivity to anidulafungin or echinocandin therapy
  • Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00037219
VER002-6
A8851018
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Vicuron Pharmaceuticals
Not Provided
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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