Clinical trial
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207…
NCT00449644 · Janssen Infectious Diseases BVBA, Industry · Completed
Key facts
| NCT number | NCT00449644 |
|---|---|
| Title | TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). |
| Official 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, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Tuberculosis |
| Intervention type | Drug |
| Interventions | TMC207, Placebo, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) |
| Enrollment | 208 |
| Start date | Jun 1, 2007 |
| Primary completion | Mar 1, 2010 |
| Completion | Oct 1, 2012 |
| First posted | Mar 20, 2007 |
| Last update posted | Apr 29, 2014 |
| Countries | Brazil, India, Latvia, Peru, Philippines, Russia, South Africa, Thailand |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: