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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00034671 |
This phase II study will be conducted to:
Condition | Intervention | Phase |
Mycoses |
Drug: Posaconazole oral suspension |
Phase II |
MedlinePlus related topics: | Fungal Infections Molds |
Drug Information available for: | Posaconazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts |
Estimated Enrollment: | 100 |
Study Start Date: | October 2000 |
This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.
The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.
Ages Eligible for Study: | 13 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | P01893 |
First Received: | May 1, 2002 |
Last Updated: | May 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00034671 |
Health Authority: | United States: Food and Drug Administration |
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