9 results
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure.Secondary:*…
Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…
The primary objectives of this study are to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for in subjects with HF and left ventricular systolic dysfunction and to characterize itspharmacokinetics (PK) after 20 weeks…
The primary objective of the clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to…
Primary: • Compare the efficacy of GSK3359609 in combination with pembrolizumab to pembrolizumab plus placebo in the PD-L1 expression positive (CPS >=1) population and in the PD-L1 expression high (CPS>=20) populationSecondary: •…
Primary:To determine the safety, tolerability, MTD (maximum tolerated dose) or the MAD (maximum administered dose) of GSK3359609 in combination with pembrolizumab or chemotherapy with(out) pembrolizumab. Secondary:To determine the recommended dose…
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
Primary:To determine whether experimental regimens provide evidence for improved survival (randomization to death) over standard of care (SoC) therapy in NSCLC patients.Secondary:Milestone survival, measures of antitumor activity, safety and…