A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Megadott ok: The Sponsor decided to stop the study for futility based on a recommendation by the IDMC following a pre-planned interim analysis
Key facts
- Where
- Budapest és Szeged, MagyarországSee the 2 sites
- Phase
- 3. fázis
Where in Magyarország
- Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztalyBudapest, MagyarországNo longer taking part
- Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelőSzeged, MagyarországNo longer taking part
Trial details
- Who runs it
- Actelion
- Trial code
- NCT04271475
- Record updated
- 2025. június 27.
- Original description
The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).Read full original descriptionShow less
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
The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
Inclusion: Chronic thromboembolic pulmonary hypertension (CTEPH) (World Health Organization [WHO] Group 4) fulfilling one of the following criteria: a) inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), b) persistent/recurrent CTEPH after balloon pulmonary angioplasty (BPA), and deemed inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), c) persistent/recurrent CTEPH after rescue pulmonary endarterectomy (PEA); 6-minute walk distance (6MWD) greater than or equal to (>=) 100 meter (m) and less than or equal to (<=) 450 meters (m), documented by an eligibility and a baseline 6-minute walk test (6MWT). The baseline 6MWD must not differ by more than 15 percent (%) from the eligibility test; World Health Organization functional class (WHO FC) >= II; Participants are to receive riociguat as per local standard of care, unless it is contraindicated or unavailable.
Exclusion: Acute pulmonary embolism within 3 months prior to or during Screening; Symptomatic coronary artery disease requiring an intervention within 3 months prior to or during Screening or anticipated during the fixed duration part of the study; 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; Administration of ERAs, intravenous prostacyclins / prostacyclin analogs, or investigational treatment within 90 days prior to Randomization; Change in dose or initiation of Phosphodiesterase type-5 (PDE-5) inhibitors, oral, inhaled or subcutaneous (SC) prostacyclins / prostacyclin analogues, prostacyclin receptor agonists or riociguat, a) within 90 days prior to Randomization, or b) anticipated during the fixed duration part of the double-blind [DB] period; 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 (for example, intermittent claudication); Decompensated cardiac failure if not under close supervision; Known and documented life-threatening cardiac arrhythmias; Known or suspicion of pulmonary veno-occlusive disease (PVOD); Severe renal dysfunction with an estimated Glomerular Filtration Rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73 m\^2) using the Chronic Kidney Disease Epidemiology Collaboration formula at Screening; Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history; Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than or equal to (>=) 1.5*upper limit of normal (ULN) at Screening; Hemoglobin <100 g/L (<10 gram per deciliter [g/dL]) at Screening; Planned balloon pulmonary angioplasty (BPA) during the fixed duration part of the double-blind period; Hypotension, that is, systolic blood pressure (SBP) less than (<) 90 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) <50 mmHg at Screening.