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NCT00391443 - Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study

Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study


CSR Summary

Not yet available


Data Specification

Not Available


Annotated CRF

Available upon approval of data request

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Product Info

Generic Name
Tracleer
Product Name
BOSENTAN®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
616
% Female
30.4%
% White
N/A
Product Class
Endothelin Receptor Antagonist
Sponsor Protocol Number
AC-052-321
Data Holder
Johnson & Johnson
Condition Studied
Idiopathic Pulmonary Fibrosis
Mean/Median Age (Years)
63.8

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

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.