13 results
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…
Primary: To study the efficacy and tolerability of Midostaurin in patients with indolent or smoldering systemic mastocytosis on mediator symptom reduction.Secondary: 1) To study whether Midostaurin can reduce mast cell infiltration and 2) to assess…
Objective of this study is to determine the efficacy of midostaurin in patients with ASM or MCL with/without an associated hematological clonal non-mast cell lineage disease.
Primary: Period II (Week 8 to Week 16)1. To demonstrate the additional antihypertensive efficacy for seated diastolic blood pressure (SeDBP) gained by adding HCTZ 12.5 or 25 mg to the treatment regimen in subjects with moderate to severe HTN not…
Main objective: * To evaluate the effect and variation of 3 and 12 months treatment with Aliskeren-based versus amlodipine-based antihypertensive treatment on aneurismal FDG- uptakeExploratory objectives: * To explore the effect of 3 and 12 months…
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ.Secondary objectives: to compare changes in the following parameters in…
To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.
Determinination of the added effects of dietary sodium restriction or diuretic use to antihypertensive and antialbuminuric therapy.
To compare the effect of amiloride on lithium-induced Nephrogenic Diabetes Insipidus with the effect of hydrochlorothiazide, measured as urine volume and maximal urine osmolality.
To demonstrate whether hydrochlorothiazide or metformin can diminish aquaresis in patients with ADPKD who are treated with tolvaptan as measured by 24-hour urine volume.
Primary: To determine the MTD and/or RDE of LGH447 with or without midostaurin. Secondary: 1. To characterize the safety and tolerability of LGH447 with or without midostaurin at the MTD and/or RDE.2. To assess any observed antitumor activity of…
Primary objective:To asses the safety and feasibility of post-transplant panobinostat combined with midostaurin in patients with adverse risk AML/RAEB with FLT3-ITD with high allelic ratio in terms of dose limiting toxicity.Secondary objectives:To…