Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
Phase 3
Completed
- Conditions
- Pulmonary hypertension / increased blood pressure in the lungs1001928010037454
- Registration Number
- NL-OMON35306
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1) Signed and dated informed consent
2) 18 to 80 years of age at Visit 1
3) Male and female patients with symptomatic PAH (Group I / Venice Clinical Classification of PH), a 6MWD test between 150 m and 450 m, a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5 and a mean pulmonary artery pressure >25 mmHg
4) Treatment naïve patients (with respect to PAH specific medication) and patients pre-treated with an Endothelin Receptor Antagonist or a Prostacycline Analoguea.
Exclusion Criteria
See page 18 - 21 of the protocol _ Paragraph 4.2.2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is change from baseline in 6 Minute Walking Distance<br /><br>(6MWD) after 12 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy endpoints are:<br /><br><br /><br>- Change from Baseline in Pulmonary Vascular Resistance (PVR) after 12 weeks<br /><br>- Change from baseline in NT-pro BNP after 12 weeks<br /><br>- Change from baseline in WHO functional class after 12 weeks<br /><br>- Time To Clinical Worsening<br /><br>- Change from baseline in Borg CR 10 Scale (measured at the end of the 6MWD<br /><br>Test) after 12 weeks<br /><br>- Change from baseline in EQ-5D questionnaire after 12 weeks<br /><br>- Change from baseline in LPH questionnaire after 12 weeks<br /><br>- Change in use of healthcare resources after 12 weeks<br /><br><br /><br>Safety Variables:<br /><br>- Treatment emergent adverse events<br /><br>- Treatment emergent serious adverse events<br /><br>- Laboratory parameters<br /><br>- ECG<br /><br>- Heart rate<br /><br>- Blood pressure<br /><br>- Blood gases</p><br>