*ASTELLAS-9463-EC-0002

Study Sponsor: Astellas

Study Title

An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects with Intra-abdominal Infections - A Multicentre, Randomized, Double-blind Study

Medicine or Vaccine (generic name)

micafungin

Sponsor Identification Number

9463-EC-0002

Trial Registry Identification Number(#'s)

NCT01122368
EudraCT 2008-006409-18

Medical Condition

Mycoses

Phase

Phase 2

Link to Astellas Study Register

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=211

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT01122368

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2008-006409-18

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

August 2017