EUCTR2007-002440-14-PTActive, not recruitingNot Applicable
A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHI
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 525
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Signed informed consent prior to initiation of any study mandated procedure.
- •2.Patients with symptomatic pulmonary arterial hypertension (PAH) in modified WHO functional class II to IV.
- •3.Patients with the following types of PAH belonging to groups 1.1 to 1.3 of the Venice classification:
- •a.Idiopathic (IPAH);
- •b.Familial (FPAH); or
- •c.Related to:
- •i.Collagen vascular disease;
- •ii.Simple, congenital systemic-to-pulmonary shunts at least 1 year post surgical repair;
- •iii.HIV infection; or
- •iv.Drugs and toxins.
- •4.PAH diagnosis confirmed by hemodynamic evaluation performed prior to randomization and showing all of the following:
- •a.Mean pulmonary artery pressure (mPAP) > 25 mmHg at rest;
- •b.Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) <= 15 mmHg; and
- •c.Pulmonary vascular resistance (PVR) at rest > 320 dyn*sec/cm5.
- •?For patients who participate in the pharmacokinetic/ pharmacodynamic substudy, hemodynamic evaluation must have been performed within 3 months prior to randomization.
- •?For all other patients, hemodynamic evaluation must have been performed within 1 year prior to randomization.
- •5.6-minute walk distance (6MWD) >= 50 m.
- •6.Men or women >= 12 years of age (women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher’s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy.
- •2.PAH associated with non corrected simple congenital systemic-to-pulmonary shunts, and combined and complex systemic-to-pulmonary shunts, corrected or non corrected.
- •3.PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
- •4.Persistent pulmonary hypertension of the newborn.
- •5.Pulmonary Hypertension belonging to groups 2 to 5 of the Venice classification.
- •6.Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration.
- •7.Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value.
- •8.Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- •9. Estimated Creatinine clearance <30mL/min
- •10.Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal.
- •11.Hemoglobin < 75% of the lower limit of the normal range.
- •12.Systolic blood pressure < 100 mmHg.
- •13.Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
- •14.Pregnant or breast-feeding.
- •15.Known concomitant life-threatening disease with a life expectancy < 12 months.
- •16.Body weight < 40 kg.
- •17.Any condition that prevents compliance with the protocol or adherence to therapy.
- •18.Recently started (< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise.
- •19.Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to randomization.
- •20.Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mTOR inhibitors).
- •21. Treatment with CYP3A inducers within 4 weeks prior to randomization.
- •22.Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- •23.Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
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