7 results
To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…
The primary objective of this study is to establish the effects of a single bolus EPO administered just before a primary PCI for a first acute myocardial infarction, on left ventricular ejection fraction after 6 weeks, measured with planar…
Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
Primary objective:• To evaluate the efficacy of luspatercept on RBC transfusion independence (RBC-TI for 12 weeks [84 days] with an associated concurrent mean hemoglobin increase >= 1.5 g/dL) compared with epoetin alfa for the treatment of…
Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…