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Sponsors and Collaborators: |
Pfizer Vicuron Pharmaceuticals |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00041704 |
Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.
Condition | Intervention | Phase |
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Candidiasis |
Drug: Anidulafungin, VER002 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis. |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | VER002-11, A8851004 |
Study First Received: | July 12, 2002 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00041704 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Azole-Refractory Mucosal Candidiasis Mucosal Candidiasis |
Anti-Bacterial Agents Mycoses Candidiasis Clotrimazole |
Miconazole Antifungal Agents Tioconazole Anidulafungin |
Anti-Infective Agents Mycoses Candidiasis Therapeutic Uses |
Antifungal Agents Antibiotics, Antifungal Pharmacologic Actions Anidulafungin |