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

This study has been completed.
Vicuron Pharmaceuticals
Information provided by:
Pfizer Identifier:
First received: May 16, 2002
Last updated: October 17, 2008
Last verified: October 2008

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.

Condition Intervention Phase
Drug: Anidulafungin, VER002
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Enrollment: 120
Study Start Date: August 2001
Study Completion Date: November 2002

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00037219

United States, Pennsylvania
Versicor, Inc.
King of Prussia, Pennsylvania, United States, 19406
Sponsors and Collaborators
Vicuron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00037219     History of Changes
Other Study ID Numbers: VER002-6, A8851018
Study First Received: May 16, 2002
Last Updated: October 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Invasive Candidiasis

Additional relevant MeSH terms:
Candidiasis, Invasive
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015