CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 252 enrolled
Drug / intervention
Posaconazole +1 moredrug
Likely dose
Posaconazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00811928
NCT00811928Phase 3Completed
CompareCT.gov

A Randomized, Open Label Parallel Controlled, Multicenter Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension Vs. Fluconazole (Capsule) in High-risk Leukopenic Patients for Prevention of Invasive Fungal Infection

Merck Sharp & Dohme LLC·interventional·Posted Dec 19, 2008·Updated Apr 7, 2017

In Brief

A Phase 3 clinical trial evaluating Posaconazole and Fluconazole for Leukopenia. Completed, enrolled 252 participants.

Detailed Summary

A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukopenia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 19, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.5 years ago

Interventions

Posaconazoledrug

40 mg/mL; 200 mg (5 mL) TID Treatment was continued with each cycle of chemotherapy until: * The onset of a proven or probable diagnosis of invasive fungal infection (IFI) * 3 chemotherapy cycles or * Total treatment duration up to 12 weeks (84 days)

Fluconazoledrug

50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules); 400 mg QD Treatment was continued with each cycle of chemotherapy until: * The onset of a proven or probable diagnosis of invasive fungal infection (IFI) * 3 chemotherapy cycles or * Total treatment duration up to 12 weeks (84 days)