Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertensio

Phase 2

Completed

• Conditions: 10014523; PAH high blood pressure in the lungs; 10037454

• Registration Number: NL-OMON41516
• Lead Sponsor: Actelion Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

- Male or female * 18 and * 80 years of age.;- Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).

Exclusion Criteria

- Previous pulmonary endarterectomy.
- Recurrent thromboembolism despite sufficient oral anticoagulants.
- Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.
- Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
- Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified