18 results
The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause…
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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 objective of this study is to assess the safety, efficacy and pharmacokinetics of 2 doses of LNG, delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 35 years of age during 3 years and with an extension…
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…
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…
Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…
The primary objective is to compare the overall survival (OS; time from randomization to death) in patients with hepatocellular carcinoma (HCC) who had disease progression during or following sorafenib therapy, or were intolerant to this agent.…
Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…
The objectives of this study are to evaluate the safety and efficacy of AGN-214868 compared with placebo in the treatment of patients with IOAB and urinary incontinence.The clinical hypotheses for this study are:• AGN-214868 has an acceptable safety…
The primary objective of this study is to evaluate the long-term maintenance of efficacy of SPD503 in childrenand adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label,short-term treatment…
The purpose of the study is to assess the effects of CER-001, given by intravenous infusion with regards to plaque burden of the carotid arteries and the descending thoracic aorta using 3T magnetic resonance imaging (3TMRI).The objective of the…
The primary objective of this study is to provide access to SPD503 following participation in SPD503-315 or SPD503-316. The primary outcome of this study is to evaluate the long-term safety of SPD503. The evaluation of safety will be based on the…
This study (AZM-MD-302) will be undertaken to confirm the effectiveness of aonce-daily oral dose of 75 mg azimilide on the reduction of unplanned cardiovascular emergencydepartment visits and hospitalizations or cardiovascular death in patients with…
The primary objectives of this study are as follows:• To determine the efficacy of treatment with GS-7977+ribavirin (RBV) compared as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (…
To evaluate the efficacy and safety of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.
The primary objective of the study is to demonstrate the reduction of LDL-C by REGN727 as add-on therapy to stable, maximally-tolerated dialy statin therapy with or without other LMT in comparison with placebo after 24 weeks of treatment in patients…