A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2007-06-01
The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral
administration of four dosing regimens of posaconazole relative to placebo and terbinafine,
in the treatment of toenail onychomycosis.
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Completed
Merck Sharp & Dohme Corp.
2006-01-01
The purpose of this postmarketing surveillance study is to collect an extensive body of data
in a large patient population in every day life to investigate the safety and efficacy of
NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
Completed
Enzon Pharmaceuticals, Inc.
Phase 3
2008-06-01
The objective of this study is to compare the safety and efficacy of ABLC versus oral
Posaconazole in the prevention of invasive fungal infections in high risk patients with
hematologic malignancies or hematopoietic stem cell transplant.
Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal
infections associated with ABLC or Posaconazole prophylaxis.
Secondary objective will be to compare the cost effectiveness of these two prophylactic
regimens.
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
Completed
M.D. Anderson Cancer Center
Phase 3
2008-06-01
The objective of this study is to compare the safety and efficacy of ABLC versus oral
Posaconazole in the prevention of invasive fungal infections in high risk patients with
hematologic malignancies or hematopoietic stem cell transplant.
Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal
infections associated with ABLC or Posaconazole prophylaxis.
Secondary objective will be to compare the cost effectiveness of these two prophylactic
regimens.
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