EUCTR2019-004131-24-HU
Active, not recruiting
Phase 1
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
DrugsOpsumit®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ACTELION Pharmaceuticals Ltd.
- Enrollment
- 230
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female \= 18 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).
Outcomes
Primary Outcomes
Not specified
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