WHO ICTRP trial

An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a…

EUCTR2008-006409-18-AT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2008-006409-18-AT
Public 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 - A Multicentre, Randomized, Double-Blind Study - INTENSE
Scientific 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 - A Multicentre, Randomized, Double-Blind Study - INTENSE
Primary sponsor Astellas Pharma Europe Ltd.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries France;Hungary;Greece;Finland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy
Conditions Invasive Candidiasis MedDRA version: 12.1 Level: LLT Classification code 10007152 Term: Candidiasis MedDRA version: 12.1 Level: LLT Classification code 10007162 Term: Candidiasis of the intestine
Interventions Trade Name: Mycamine Product Name: Micafungin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: MICAFUNGIN CAS Number: 235114-32-6 Current Sponsor code: FK463 Concentration unit: mg milligram(s) Concentration type…
Registration date Jan 19, 2010
Target size 250
Secondary IDs 9463-EC-0002
Registry page clinicaltrialsregister.eu

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