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NCT00037219 Clinical Trial

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

Candidiasis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00037219
Other study ID # VER002-6
Secondary ID A8851018
Status Completed
Phase Phase 2
First received May 16, 2002
Last updated October 17, 2008
Start date August 2001
Est. completion date November 2002

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date November 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anidulafungin, VER002

Locations
Country Name City State
United States Versicor, Inc. King of Prussia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States, 

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