61 results
This study is being conducted to provide a preliminary assessment of whether BL-5010 sloughs off SK lesions and has an acceptable safety profile (including no or minimal dermal irritation following the application at the site of the SK lesion).…
For Part A: the purpose of this part is to investigate the effect of multiple oral doses of the new study drug on how quickly and to what extent glimepiride is absorbed and eliminated from the body (this is called pharmacokinetics), if glimepiride…
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Primary objective:To determine the pharmacokinetics of E7080 and its excretion balance in order to elucidate its metabolic profile in plasma, urine, and feces following a single oral dose of radiolabeled 14C-E7080 in patients with advanced tumors or…
PART A: To assess the efficacy of BAY 94-9027 in prevention and treatment of bleeding at different infusion schedules.PART B: To assess the safety and efficacy of BAY 94-9027 in the prevention of bleeding during major surgical procedures.
Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…
The main objective is to examine if 68Ga-exendin tracer accumulation (i.e. beta cell mass) differs in patients with persisting HH after RYGB compared to matched patients without HH after RYGB. The secondary objectives are:- compare GLP1 and GIP…
The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…
To evaluate the efficacy, safety, pharmacology, and patient-reported outcomes of the combination of taselisib plus fulvestrant compared to placebo plus fulvestrant in ER+, HER2- postmenopausal women with locally advanced or MBC and who have had…
Program-specific Objective:To assess the impact of MK-3102 25 mg q.w. on time to confirmed CV outcomes as measured by the time to first event in the CVcomposite endpoint of CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring…
The primary objective of this study is to evaluate the efficacy of different doses of TA 8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high density lipoprotein cholesterol (HDL C) and reduction of low density…
The purpose of this study is: * To test the safety of the research study drug MK-3102.* To assess how well the research study drug MK-3102 lowers blood sugar levels (fasting plasma glucose [FPG], post meal glucose [PMG], and glycosylated hemoglobin…
Ex vivo study: What is the relation between increasing heparin concentrations and different protamine:heparin-ratio*s with POC-PT values in blood drawn from healthy volunteers?Clinical study in cardiac surgery: Does the POC-PT device correspond with…
Primary Objective: To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated. . Secondary Objective(s): To study the composite…
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. The incidence of adverse events over 12 month treatment period will be the main…
The objective of the study is to assess the efficacy and safety of Alirocumab in patients with heterozygote familial hypercholesterolemia whose LDL-C level is higher than or equal to 160 mg/dL (4.14 mmol/L) on maximally tolerated statin therapy with…
To evaluate the efficacy and safety of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.
The main objective of the trial is to identify at least one NGR that will demonstrate all of the following:1. Inhibition of ovulation2. Cycle control that is non-inferior to NuvaRing®, as judged by the incidence ofBTB-S during Treatment Cycle 3. The…
The primary objective of this study is to compare the efficacy of eprotirome 50 microgram and eprotirome 100 micorgram versus placebo in terms of the percent change in LDL-C from baseline to Week 12 in HeFH patients with CAD, or who are at high risk…
Primary1. To evaluate the safety, tolerability and pharmacokineticproperties of RO5428029 in healthy subjects and chronichepatitis C genotype 1 infected patients.2. To evaluate pharmacodynamics (viral load response) ofRO5428029 in chronic hepatitis…