drugset / Trial / NCT02180165

Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)

NCT02180165

Phase 3 Completed 116 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.

Timeline

Start
2014-07-29
Primary completion
2018-01-24
Completion
2018-01-24

Publications

  • Results "Kohno S, Izumikawa K, Yoshida M, Okada F, Mori T, Najima Y, Waskin H, Shizuya T, Fukuhara T, Adachi N, Niki Y. A Randomized, Active-controlled, Open-label, Comparative Study to Assess the Safety and Efficacy of Posaconazole in Japanese Subjects with Deep-seated Fungal Infection. Nihon Ishinkin Gakkai Zasshi. 2020; 61(1):1-11. PDF file: https://www.jstage.jst.go.jp/article/ishinkin/61/1/61_19-00015/_pdf/-char/ja Web page: https://www.jstage.jst.go.jp/article/ishinkin/61/1/61_19-00015/_article/-char/ja"

Drugs

EvaluationDrugModalityDoseRoute
Subject Posaconazole Small molecule 300 mg Oral
Comparator Voriconazole Small molecule 4 mg/kg Oral
Comparator Voriconazole Small molecule 200 mg Oral

Indications