4 results
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
Primary ObjectivesThe primary objectives of this study are to evaluate the analgesic effect size over 12 weeks of several doses and dosage regimens of JNJ-42160443 compared with placebo in subjects with moderate to severe, chronic, low back pain (…
Primary objective : Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients (no antidiabetic drug treatment in the last 6 months), with type 2 diabetes mellitus and dyslipidemia, to show that : - the efficacy of a…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…