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NCT00433329 - COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling

COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling


CSR Summary

Not Available


Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Bosentan
Product Name
TRACLEER®
Therapeutic Area
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
100
% Female
82.0%
% White
N/A
Product Class
Endothelin Receptor Antagonist
Sponsor Protocol Number
AC-052-419
Data Partner
Johnson & Johnson
Condition Studied
Hypertension, Pulmonary, Arterial
Mean/Median Age (Years)
55.5

Supporting Documentation

Clinical Study Report
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
4
Additional Information: 

Please note: Participant-level data is not available for this study. Only the Protocol with Amendments, Statistical Analysis Plan, and Clinical Study Report are available.

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.