An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial

Phase 3

Completed

• Conditions: -Chronic thromboembolic pulmonary hypertension (Dana Point classification class 4); High pressure in the arteries of the lungs due to blood clotting and structural changes; 10037454

• Registration Number: NL-OMON38503
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

Exclusion Criteria

- All types of pulmonary hypertension other than Dana Point Classification Group 4
- Operable patients listed for PEA (Pulmonary Endarterectomy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There are no primary variables. Within this open-label long-term surveillance<br /><br>study safety and tolerability as well as clinical effects will be measured.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>