7 results
The primary objective of this study is to assess the safety of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD in children or adolescent patients with high-risk hyperlipidaemia over a period of 52 weeks.The secondary objective of this study is to assess…
The primary objective of this study is to compare the efficacy of pitavastatin 1 mg once daily (QD), 2 mg QD, and 4 mg QD (after up-titration) to placebo in terms of the percentage reduction in LDL-C in children or adolescent patients with high-risk…
The primary study objective is to evaluate the Model 106 VNS Therapy® System cardiac-based seizure detection and Automated Magnet Mode (AMM) stimulation in epilepsy patients. These two new features will be evaluated using continuous observational…
Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…
Primary objectiveTo determine the effect of steady state boceprevir on the pharmacokinetics (AUC0-12h, Cmax, C12h) of a single dose raltegravir.Secondary objectives:To determine the effect of a single dose raltegravir on the pharmacokinetics (AUC0-…
Document the efficacy and tolerability of 12 weeks of Boceprevir (Victrelis®) therapy in addition to standard of care (SOC) therapy consisting of weekly weight based peginterferon alfa-2b (Pegintron®) SC and ribavirin PO BID, for the treatment of…
To assess long-term safety and tolerability of pitavastatin 4 mg once daily (QD)To assess the efficacy of pitavastatin (4 mg QD) and simvastatin (40 mg and 80 mg QD) in terms of LDL-C target attainment (European Atherosclerosis Society [EAS] and…