12 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…
Main objective: To evaluate the pain reduction in patients receiving Instanyl®Secondary objectives: To evaluate; the duration of pain reduction in patients receiving Instanyl®; the degree of adverse effects in patients receiving Instanyl®: whether…
The objective of this study is to investigate what the effects of LCZ696 or amlodipine are on insulin sensitivity as assessed by hyperinsulinemic euglycemic glucose clamp (HEGC) after 8 weeks of treatment. Furthermore, the effects on subcutaneous…
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
The primary objective is to compare the percentage of patients reaching an effective FBT dose with a starting dose of 100 mcg to those with a starting dose of 200 mcg. Secondary objectives are to evaluate the safety and tolerability and the…
This trial assesses the safety profile of GRT6005 in terms of its effect on respiratory function. Data on its effect on ventilation in a model of respiratory depression will be obtained and compared to fentanyl (a strong opioid with comparable…
The primary objective of this study is to determine the efficacy and safety of different doses of LCZ696 compared to valsartan. In addition, the efficacy and safety of AHU377 as compared to placebo is evaluated.
The primary objective of this study is to continue to evaluate the safety and tolerability of LCZ696 in heart failure patients from PARADIGM-HF receiving open-label investigational drug.There are no secondary objectives for this study.
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-…
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary…
To determine whether VSA treatment with the novel ERA macitentan reduces the frequency and severity of anginal complaints among patients with clinically defined VSA. To determine side effects related to treatment with macitentan in patients with VSA…