54 results
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…
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…
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 male and female patients at least 55 years of…
The main study aim is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of children (< 16 years) with proven endogenous congenital hyperinsulinism who qualify for surgery based on response…
Primary objective:To demonstrate the efficacy of dupilumab administered concomitantly with TCS through week 16 in adult patients with moderate-to-severe atopic dermatitis (AD).Secondary objectives:Evaluate long-term efficacy of dupilumab when…
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein (LDL) cholesterol (LDL-C) by REGN727 in comparison with ezetimibe (EZE) 10 mg PO QD after 24 weeks in patients with primary hypercholesterolemia (…
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…
Primary objective:Evaluate the effect of two doses versus placebo gantenerumab subcutaneous injections on the change in Clinical Dementia Rating Sum of Boxes scale (CDR SOB), a global measure of cognition and functional capacitySecondary objectives:…
The objective of the study is to assess the efficacy, tolerability and safety of SAR236553/Alirocumab when administered during 1.5years in patients with heterozygote familial hypercholesterolemia, who despite of lipid lowering therapy still have…
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 (…
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…
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 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 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…
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…