Trials / Completed
CompletedNCT02180165
Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
A Randomized, Comparative, Open-label Study to Assess the Safety and Efficacy of MK-5592 Compared With Voriconazole in Japanese Subjects With Deep-seated Fungal Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Posaconazole | 300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days |
| DRUG | Voriconazole | 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days |
Timeline
- Start date
- 2014-07-29
- Primary completion
- 2018-01-24
- Completion
- 2018-01-24
- First posted
- 2014-07-02
- Last updated
- 2021-01-28
- Results posted
- 2019-01-11
Source: ClinicalTrials.gov record NCT02180165. Inclusion in this directory is not an endorsement.