29 results
Primary: to estimate progression-free survival in patients treated with everolimus + letrozole in the first line setting.Secondary: overall response rate, clinical benefit rate, overall survival in the first line setting, progression free survival…
PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…
Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 10 in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy. Empagliflozin is…
The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 2,5mg, 10mg and 25mg in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy.…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…
Primary:The primary objective of this trial is to evaluate whether empagliflozin 10mg/day will relieve dyspnea, improves diuretic response, decreases length of initial hospital stay and NT-proBNP compared to placebo during hospital admission for…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction (LVEF * 40%).
Primary objective:To determine whether there is a difference in overall survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control armconsisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)…
Primary Objective • To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) or weight in patients with T2D following 65 weeks of treatment. The non-inferiority margins…
Main study objective is to find out which dose among three different doses of LIK066 is the most efficacious, safe and well tolerated in type 2 diabetes patients with heart failure. We will also learn which medication is better at managing patients…
Primary objective: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…
To examine the effects of mono- and combination therapy with linagliptin and empagliflozine on renal hemodynamics
The aim of the study is to determine whether conducting a randomized placebo-controlled clinical trial is feasible, safe for the patient and whether the treatment is well tolerated in patients with idiopathic pulmonary arterial hypertension.
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.
The main objective of this study is to assess whether in-hospital administration of empagliflozin results in improvement in HF-related outcomes in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) and after initial…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…