12 results
The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…
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…
Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…
To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency. The dose response…
To evaluate the long term safety and tolerability of GWP42003-P, as adjunctive treatment, in children and adults with inadequately controlled DS or LGS.All Patients:To evaluate the effect of GWP42003-P, as adjunctive treatment, on:* Quality of life…
Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…
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 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 efficacy of GWP42003-P as adjunctive treatment inreducing the number of drop seizures when compared with placebo, inpatients with LGS.Drop seizure is defined as an attack or spell (atonic, tonic or tonic-clonic)…
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 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…
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…