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NCT00660179 - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hyperten

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension


CSR Summary

Not Yet Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Macitentan
Product Name
OPSUMITĀ®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
742
% Female
76.1%
% White
N/A
Product Class
Endothelin Receptor Antagonist
Sponsor Protocol Number
AC-055-302
Data Partner
Johnson & Johnson
Condition Studied
Hypertension, Pulmonary, Arterial
Mean/Median Age (Years)
45.6

Supporting Documentation

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

Disclaimer

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