Trial intelligence / Profile preview

Phase 3 trial of delamanid plus optimized background regimen for pulmonary multidrug-resistant tuberculosis

2010-022271-59Phase 3Completed

Sponsor
Otsuka Pharmaceutical Development & Commercialization
Start
May 2011
Modality
Small Molecules
Countries
1
01

Overview

Phase 3, randomised, double-blind trial in pulmonary tuberculosis (TB) comparing Delamanid + optimized background regimen with Placebo + optimized background regimen (2 arms). Primary endpoints: Proportion of patients achieving sputum culture conversion at 2 months using MGIT and Distribution of time to sputum culture conversion using MGIT during the intensive treatment period. Started May 2011; status: completed.

02

Drugs

delamanid
03

Conditions

pulmonary tuberculosis (TB)

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