6 results
The primary objective of this multicenter, parallel design, prospective, randomized clinical trial, with repeated observations over time, is to compare the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT based on an open…
Primary objectivesWhat is the quality of MR images acquired on the MR-HIFU breast system in volunteers and patients with a fibroadenoma relative to the quality of MR images acquired on a conventional diagnostic 3-Tesla MRI scanner? We will assess…
Primary objective:the primary objective of the study is to evaluate the safety and to define the maximal tolerated dose or the maximal administered dose of CC-486 as a single agent, in combination with CBDCA or ABI-007 in subjects with relapsed or…
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…
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).