6 results
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 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…
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…
Primary objectives: To evaluate safety of ZED88082A in combination with CED88004S. To determine appropriate ZED88082A/CED88004S dosing and PET imaging time-points. To evaluate pharmacokinetics (PK) of ZED88082A/CED88004S in patients before and…
Primary objectives:The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell…
Primary objective (Parts A and B):To evaluate the long-term safety and tolerability of VX-445/TEZ/IVA in subjects with CF who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation.Secondary objectives (…