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NCT00303459 - Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel

Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study


CSR Summary

Not Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Bosentan
Product Name
TRACLEER®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
334
% Female
75.7%
% White
88.6%
Product Class
Endothelin Receptor Antagonist
Sponsor Protocol Number
AC-052-414 (COMPASS-2)
Data Partner
Johnson & Johnson
Condition Studied
Hypertension, Pulmonary, Arterial
Mean/Median Age (Years)
53.9

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
4

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.