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

This study has been completed.

Sponsor:

Collaborator:

Vicuron Pharmaceuticals

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00037219

First received: May 16, 2002

Last updated: October 17, 2008

Last verified: October 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	May 16, 2002
Last Updated Date	October 17, 2008
Start Date ^ICMJE	August 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00037219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
Official Title ^ICMJE	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
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Candidiasis
Intervention ^ICMJE	Drug: Anidulafungin, VER002
Study Arm (s)	Not Provided
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 ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	November 2002
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00037219
Other Study ID Numbers ^ICMJE	VER002-6, A8851018
Has Data Monitoring Committee	Not Provided
Responsible Party	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Vicuron Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Pfizer
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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