13 results
To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remissionTo determine whether restarting of Imatinib in case of molecular relapse results in a…
Primary:- To determine the MTD and/or a recommended phase II dose (RP2D) of BYL719 when administered orally in combination with imatinib 400 mg q.d.Secondary:- Assess the safety and tolerability profile of imatinib and BYL719 administered in…
This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib
The primary objectives of this study are:- To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT proBNP from baseline after 12 weeks of treatment in patients with HFpEF.- To demonstrate that LCZ696…
To evaluate the effects of LCZ696 compared to valsartan on cognitive function over 3 years in patients with HFpEF as assessed by the CogState cognitive assessment battery.
To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Mortality.
The primary objective:To compare LCZ696 to valsartan in reducing the rate of the composite endpoint of cardiovascular death andtotal (first and recurrent) heart failure (HF) hospitalizations, in HF patients (NYHA Class II-IV) with preserved EF (LVEF…
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.
Primary: To evaluate the long-term safety and tolerability of QTI571.Secondary: * Continue to evaluate the long-term efficacy of QTI571 as measured by the change in6MWD from baseline.* Continue to assess time to clinical worsening (TTCW) endpoints…
The primary objective of the study is to evaluate the efficacy of aliskiren, valsartan and a combination of both drugs versus placebo in lowering levels of NT-proBNP in stabilized patients post ACS
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
To demonstrate the efficacy of LCZ696 in patients with chronic heart failure with preserved ejection fraction (HF-PEF) by testing the hypothesis that the reduction in NT-proBNP from baseline to study end with LCZ696 is greater than that with…
Primary:* Determine the maximum tolerated dose (MTD) and/or a recommended Phase II dose (RP2D) of BKM120 when administered in combination with imatinib 400 mg q.d.Secondary:* Assess the safety and tolerability profile of imatinib and BKM120…