Overview

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Riociguat
Criteria
Inclusion Criteria:

- Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH
due to connective tissue disease, congenital heart disease, portal hypertension with
liver cirrhosis, or due to anorexigen or amphetamine use)

- Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a
Prostacyclinanalogue (except I.V.).

Exclusion Criteria:

- All types of pulmonary hypertension except subtypes of Venice Group I specified in the
inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled
arterial hypertension, left heart failure.