Study Phase 2

A Phase II, Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).

Trial Information

Generic NameBedaquiline/TMC207Product NameSIRTURO®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment208% Female35.6%% White24%
Product ClassAntimycobacterial AgentsSponsor Protocol NumberCR011929, TMC207-TIDP13-C208, 2007-004462-40Data PartnerJohnson & JohnsonCondition StudiedTuberculosisMean/Median Age (Years)32

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available

Approved Data Requests Associated with this Trial

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