Skip to main content

NCT00449644 - 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 Resistan

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).

Data Request Dashboard

Operations

No data requests found. Click here to generate a new one.


Data Specification

Not Yet Available


Annotated CRF

Not Yet Available

Product Info

Generic Name
Bedaquiline/TMC207
Product Name
SIRTURO®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
208
Product Class
Antimycobacterial agents
Sponsor Protocol Number
CR011929, TMC207-TIDP13-C208, 2007-004462-40
Data Holder
Johnson & Johnson
Condition Studied
Tuberculosis

Supporting Documentation

Analysis Datasets
Annotated Case Report Form (CRF)
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.