ong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Phase 3
Withdrawn
- Conditions
- 1001928010037454Pulmonary hypertension / increased blood pressure in the lungs
- Registration Number
- NL-OMON37076
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1) Signed and dated informed consent
2) Patients who have completed 16 weeks of treatment in the CHEST-1 trial.
Exclusion Criteria
See page 13 of the protocol _ Paragraph 4.2.2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints are safety and tolerability of a long-term treatment with BAY<br /><br>63-2521.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary endpoints are:<br /><br><br /><br>- Change from baseline in 6 MWD test<br /><br>- Change from baseline in NT-pro BNP<br /><br>- Change from baseline in WHO functional class<br /><br>- Time To Clinical Worsening<br /><br>- Change from baseline in Borg Dyspnoea Score (measured at the end of the 6MWD<br /><br>Test)<br /><br>- Change from baseline in EQ-5D questionnaire<br /><br>- Change from baseline in LPH questionnaire<br /><br>- Change in use of healthcare resources</p><br>