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Clinical trial

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).

NCT00449644 is registered in ClinicalTrials.gov with Janssen Infectious Diseases BVBA as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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).
Lead sponsor
Janssen Infectious Diseases BVBA
Phase
Phase 2
Overall status
Completed
Start date
June 30, 2007
Completion date
October 31, 2012
Enrollment
208 (actual)
Sites
16

Conditions

As the registry lists them; a condition with its own page is linked.