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NCT01106014 - A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension


CSR Summary

Not Yet Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

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Operations

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Product Info

Generic Name
Selexipag
Product Name
UPTRAVIĀ®
Therapeutic Area
Heart and Blood Diseases
Enrollment
1,156
% Female
79.8%
% White
65.0%
Product Class
Prostacyclin receptor agonist
Sponsor Protocol Number
AC-065A302
Data Holder
Johnson & Johnson
Condition Studied
Hypertension, Pulmonary Arterial
Mean/Median Age (Years)
48.1

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
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.