9 results
Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).
Primary objective* To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).Secondary objectives* To…
The objective of this cross-sectional study is to assess the relation between plaque characteristics, detected by Coronary Computed Tomography Angiography (CCTA) and Intravascular Optical Coherence Tomography (IVOCT), and the hemodynamic…
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
The primary objective of this study is to compare the efficacy of pitavastatin 1 mg once daily (QD), 2 mg QD, and 4 mg QD (after up-titration) to placebo in terms of the percentage reduction in LDL-C in children or adolescent patients with high-risk…
To assess long-term safety and tolerability of pitavastatin 4 mg once daily (QD)To assess the efficacy of pitavastatin (4 mg QD) and simvastatin (40 mg and 80 mg QD) in terms of LDL-C target attainment (European Atherosclerosis Society [EAS] and…
The primary objective of this study is to assess the safety of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD in children or adolescent patients with high-risk hyperlipidaemia over a period of 52 weeks.The secondary objective of this study is to assess…
Primary objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…
To determine the effect of Pre-OP, in addition to perioperative intravenous antimicrobial prophylaxis on the cumulative incidence of deep surgical site infections (SSI) and/or mortality within 30 days after surgery in patients undergoing elective…