A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH

ACTELION Pharmaceuticals Ltd.0 sites230 target enrollmentFebruary 2, 2021

ConditionsChronic thromboembolic pulmonary hypertension MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

DrugsOpsumit®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic thromboembolic pulmonary hypertension
Sponsor: ACTELION Pharmaceuticals Ltd.
Enrollment: 230
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 2, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ACTELION Pharmaceuticals Ltd.

Eligibility Criteria

Inclusion Criteria

•Male or female \= 18 (or the legal age of consent in the jurisdiction in which the study is taking place)and \=80 years of age.
•CTEPH (WHO Group 4\) fulfilling one of the following criteria:
•a. Inoperable due to the localization of the obstruction being surgically inaccessible (ie, distal disease) as confirmed by the adjudication committee (AC), and diagnosed based on
•At least 2 of the following assessments in the 14 month\-period prior to Randomization: Ventilation / Perfusion (V/Q) scan, pulmonary angiography (PA), computed tomography pulmonary angiogram (CTPA), magnetic resonance angiography (MRA).
•\- RHC at least 12 weeks after full anticoagulation showing the following (at Screening or in the 24 week period prior to Randomization): mPAP \> 20 mmHg, PAWP \=15 mmHg and PVR \=240 dyn·sec/cm5\.
•b. Persistent/recurrent CTEPH after BPA, and deemed inoperable due to the localization of the obstruction being surgically inaccessible (ie, distal disease) as confirmed by the AC, diagnosed based on:
•At least one of the following assessments performed after the latest BPA in the 14\-month period prior to Randomization: V/Q scan, PA, CTPA or MRA
•RHC at least 12 weeks after BPA and full anticoagulation showing the following (at Screening or in the 24\-week period prior to Randomization): mPAP \> 20 mmHg, PAWP \=15 mmHg and PVR\=240 dyn·sec/cm5\.
•c. Persistent/recurrent CTEPH after PEA (including PEA followed by BPA), diagnosed based on:
•At least one of the following assessments performed after the PEA (and latest BPA following PEA, if applicable) in the 14\-month period prior to Randomization: V/Q scan, PA, CTPA or MRA.

Exclusion Criteria

•Acute pulmonary embolism within 6 months prior to or during Screening.
•Planned (during the double\-blind period of the study) BPA.
•Significant obstructive and restrictive lung disease.
•Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements, in particular with 6MWT (eg, intermittent claudication).
•Symptomatic coronary artery disease requiring an intervention within 3 months prior to or during Screening or anticipated during the DB period of the study.
•Decompensated cardiac failure if not under close supervision.
•Known and documented life\-threatening cardiac arrhythmias.
•Acute myocardial infarction within 6 months prior to, or during Screening.
•Cerebrovascular events (including transient ischemic attack) within 3 months prior to, or during Screening.
•Known or suspicion of pulmonary veno\-occlusive disease (PVOD).