Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
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 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Detailed Description
Adverse event data will be covered in Adverse events section.
Eligibility Criteria
Inclusion
- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.
Exclusion
- All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.
Key Trial Info
Start Date :
February 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2012
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00855465
Start Date
February 23 2009
End Date
June 27 2012
Last Update
November 21 2023
Active Locations (89)
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1
La Jolla, California, United States, 92093
2
Sacramento, California, United States, 95817
3
Miami, Florida, United States, 33136
4
Iowa City, Iowa, United States, 52242