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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Phase 3

Completed

Conditions: Pulmonary hypertension / increased blood pressure in the lungs
10019280
10037454

Registration Number: NL-OMON37288

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

1) Signed and dated informed consent
2) 18 to 80 years of age at Visit 1
3) Male and female patients with CTEPH and a 6MWD Test between 150 m and 450 m either
defined as:
a) Inoperable due to the consideration of an experienced surgeon, with
pulmonary vascular resistance >300 dyn*sec*cm-5 measured at least 90 days after start of full anticoagulation and mean pulmonary artery
pressure >25 mmHg
b) With persisting or recurrent PH after Pulmonary Endarterectomy
4) Unspecific treatments which may also be used for the treatment of pulmonary
hypertension such as oral anticoagulants, diuretics, digitalis, calcium channel
blockers or oxygen supplementation are permitted. ;See page 15 - 17 of the protocol Paragraph 4.2.1

Exclusion Criteria

See page 17 - 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 16 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 16 weeks<br /><br>- Change from baseline in NT-pro BNP after 16 weeks<br /><br>- Change from baseline in WHO functional class after 16 weeks<br /><br>- Time To Clinical Worsening<br /><br>- Change from baseline in Borg CR10 Score (measured at the end of the 6MWD<br /><br>Test) after 16 weeks<br /><br>- Change from baseline in EQ-5D questionnaire after 16 weeks<br /><br>- Change from baseline in LPH questionnaire after 16 weeks<br /><br>- Change in use of healthcare resources after 16 weeks<br /><br><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>