Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Bayer
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2012
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT00810693
Start Date
December 17 2008
End Date
May 14 2012
Last Update
November 22 2023
Active Locations (122)
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1
Tucson, Arizona, United States, 85724
2
La Jolla, California, United States, 92037
3
Los Angeles, California, United States, 90073
4
Sacramento, California, United States, 95817