WHO ICTRP trial

A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine…

EUCTR2008-004583-40-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2008-004583-40-DE
Public title A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine added to standard primery therapy in elderly patients with newly diagnosed AML. - AML-AZA
Scientific title A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine added to standard primery therapy in elderly patients with newly diagnosed AML. - AML-AZA
Primary sponsor Universitaetsklinikum Muenster
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Germany
Conditions The disease under investigation is newly diagnosed Acute Myeloid Leucemia (AML) in elderly patients. MedDRA version: 13.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign…
Interventions Trade Name: Vidaza (MA in USA and Switzerland) Product Name: azacitidine Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: AZACITIDINE CAS Number: 320672 Concentration unit: mg milligram(s) Concentration type…
Registration date Jul 1, 2009
Target size 234
Secondary IDs 101010
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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