drugset / Trial / NCT01600963

A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis

NCT01600963

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.

Timeline

Start
2014-03
Primary completion
2016-07
Completion
2022-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bedaquiline Small molecule 200 mg Oral