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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR POSACONAZOLE

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Clinical Trials for Posaconazole

Trial ID Title Status Sponsor Phase Summary
NCT00002399 A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients Completed Schering-Plough Phase 2 The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.
NCT00002446 Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients Completed Schering-Plough Phase 3 The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.
NCT00033982 Posaconazole to Treat Invasive Fungal Infections Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 This study will evaluate the safety and effectiveness of posaconazole for treating invasive fungal infections. New therapies for these infections are needed for patients who do not respond, to or cannot tolerate, standard treatment. These patients include those with immune defects who have significant side effects from treatment with amphotericin or other antifungals. Patients 13 years of age or older who are on other primary NIH protocols with an invasive fungal infection 1) that does not respond to standard antifungal therapies; 2) for which there is no effective therapy; 3) who develop serious side effects from their current treatment; or 4) who have organ dysfunction that does not permit use of standard antifungal treatments may be eligible for this study. Candidates will be screened with a medical history, including a review of current and previous antifungal treatments, pregnancy test for women of childbearing potential, electrocardiogram (EKG), and detailed neurologic examination. Participants will take either 200 mg (1 teaspoonful) of liquid posaconazole by mouth four times a day or 400 mg (two teaspoonfuls) twice a day for a period of 28 days to 24 months. (The physician will determine the duration of treatment.) Patients will have monthly follow-up visits during the treatment period and 1 month after treatment is completed for the following procedures: - Detailed neurologic exam every 3 months - Blood tests every month - EKG every month - Imaging studies, including chest x-ray, computed tomography (CT), magnetic resonance imaging (MRI) radionuclide scanning or ultrasound, every month until the infection has been stable for three determinations. Thereafter, imaging studies will be done every 3 months as long as the infection remains stable or improves. On the last day of the study treatment period, participants will have a detailed neurologic exam and review of medications and medical complaints since their last visit.
NCT00034632 Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095) Completed Merck Sharp & Dohme Corp. Phase 3 This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.
NCT00034645 Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease Completed Merck Sharp & Dohme Corp. Phase 3 This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).
NCT00034658 Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041) Completed Merck Sharp & Dohme Corp. Phase 3 This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A: which are refractory or resistant to standard antifungal therapies; B: for which there are currently no effective therapies; C: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.
NCT00034671 PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893) Completed Merck Sharp & Dohme Corp. Phase 2 This phase II study will be conducted to: 1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and 2. identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Posaconazole

Condition Name

Condition Name for Posaconazole
Intervention Trials
Fungal Infection 12
Mycoses 9
Fungal Infections 5
Myelodysplastic Syndromes 4
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Condition MeSH

Condition MeSH for Posaconazole
Intervention Trials
Mycoses 34
Infection 14
Communicable Diseases 8
Leukemia, Myeloid, Acute 8
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Clinical Trial Locations for Posaconazole

Trials by Country

Trials by Country for Posaconazole
Location Trials
United States 60
Netherlands 6
Belgium 6
Spain 6
Germany 5
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Trials by US State

Trials by US State for Posaconazole
Location Trials
Texas 9
Pennsylvania 5
New York 5
California 4
Illinois 4
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Clinical Trial Progress for Posaconazole

Clinical Trial Phase

Clinical Trial Phase for Posaconazole
Clinical Trial Phase Trials
Phase 4 15
Phase 3 13
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Posaconazole
Clinical Trial Phase Trials
Completed 37
Recruiting 12
Not yet recruiting 7
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Clinical Trial Sponsors for Posaconazole

Sponsor Name

Sponsor Name for Posaconazole
Sponsor Trials
Merck Sharp & Dohme Corp. 29
Schering-Plough 4
Radboud University 4
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Sponsor Type

Sponsor Type for Posaconazole
Sponsor Trials
Industry 49
Other 47
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

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Healthtrust
Express Scripts
Fish and Richardson
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Johnson and Johnson
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