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Safety and Efficacy of Delamanid for MDR-TB
NCT01424670Phase 3Completed
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization
- Start
- Sep 2011
- Primary completion
- Jul 2016
- Modality
- Small Molecules
- Countries
- 7
01
Overview
Phase 3, randomised, double-blind trial in multidrug-resistant tuberculosis (MDR-TB) comparing Delamanid + OBR with Placebo + OBR (2 arms). Primary endpoint: Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System. Started Sep 2011; status: completed.
02
Drugs
delamanid
03
Conditions
multidrug-resistant tuberculosis (MDR-TB)
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