12 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…
1) To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoproteincholesterol (LDL-C) after 24 weeks of treatment in patients with diabetes treated with insulin and with…
To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.
Primary Objectives• To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia neuralgia • To…
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: To evaluate the efficacy of alirocumab, on low-density lipoprotein cholesterol (LDL-C) levels of treatment in children with homozygous familialhypercholesterolemia (hoFH) 8 to 17 years of age on top of background treatments.…
Primary objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age of 8 to 17 years, with LDL-C *130 mg/dL (3.37…
Primary objectiveTo determine whether the clinical response after 10-day oral administration of cadazolid is non-inferior to oral vancomycin in subjects with CDAD.Secondary objectivesTo determine whether oral administration of cadazolid for 10 days…
The primary objective of the study is to evaluate neurocognitive function with use of Praluent after 96 weeks of treatment versus placebo.
Primary objective- To evaluate the effect of LDL-C lowering by means of the PCSK9 inhibitor alirocumab as compared with placebo on the change in percent atheroma volume (PAV) in non-infarct-related coronary arteries of patients who present with…
This first-in-man study will investigate the safety and tolerability as well as establish a recommended dose of INCB081776 as a monotherapy (Part 1) and then in combination with INCMGA00012 (Part 2) in participants with advanced malignancies. During…
Primary goal: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in children with heterozygous familial…