13 results
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the EMA in providing additional safety and efficacy data in approximately 150 patients with Ph+ CML whose disease had failed or who are otherwise not…
To investigate whether treatment with candesartan (ARB) reduce 24-hours systolic BP and aortic stiffness more effectively than treatment with metoprolol (beta-blocker) in patients with repaired CoA and late hypertension.
To compare sympathetic and haemostatic activity in rest and after rising in patients with chronic heart failure and healthy subjects, who will be randomly assigned to selective and nonselective beta-blockers. To analyse whether haplotypes of two…
To assess in term pregnant women with an unfavourable cervix (Bishop score < 6, Appendix1) the effectiveness of induction of labour with a transcervical Foley catheter as compared to induction with prostaglandins.
To objective the most efficacy way to ripening the cervix of pregnant women.
Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…
The purpose of this study is to investigate how quickly and to what extent bosutinib is absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule will be compared to the…
The objectives of the current study are:1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (i.e., studies B1871006 and B1871008) and who…
Primary Objective phase 1:- To determine the Recommended Phase 2 Dose (RP2D) of bosutinib for R/I (RP2DR/I) and ND chronic phase (RP2DND) pediatric patients withCML, based on the pharmacokinetic, safety and tolerability profile of bosutinib observed…
Primary:To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of patients that are in Major Molecular Response at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within…
Primary: To compare the Major Molecular Response (MMR) rate at 24 weeks of ABL001 versus bosutinibSecondary: To compare additional parameters of the efficacy of ABL001 versus bosutinib. Safety, tolerability.
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
To test the acute effect of beta-blockers vs flecainide on the reduction of PVCs in a pediatric population. Secondary objectives are to perform a prospective evaluation of the effect of PVCs on LV function, to test the effect of reduction of PVCs by…