12 results
The primary objective is to select one of two platinum strategies to be used in this regimen for use as experimental arm in Phase III. This is a screening feasibility study addressing purely investigational approaches.
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).
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
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…
Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation. Treatment includes:a. intrathecal administration of rituximab, B. combining R-DHAP with high dose methotrexate intravenously.The following endpoints will be…
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-…
Neuroendocrine carcinomas are distinguished clinically from neuroendocrine tumours by their rapid growth and early development of metastases. Both large and small cell neuroendocrine carcinomas are generally treated based upon chemotherapy regimens…
This study investigates whether chemoradiotherapy (45 Gy in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC (epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival in…
The objective of this trial is to collect additional safety data.The further objective of this trial is to collect long-term efficacy measures as well as to assess the treatment effect on:- disability and productivity- functional impairment- health-…
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…
The primary objective of this trial in CIAS is to assess the efficacy in improving cognitive impairment using MCCB in patients with schizophrenia treated for 26 weeks with Iclepertin 10mg as compared with placebo.