7 results
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…
Primary objective:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV…
Primary:• To evaluate the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels (<= 50 ng/dL [1.7 nmol/L]) in men with androgen-sensitive advanced prostate cancer.Secondary:• To evaluate the time…
Primary:* To obtain data on long term safety and tolerability on vedolizumab SC in subjects with Ulcerative Colitis (UC) or Crohn's Disease (CD).Secondary:* To obtain data on adverse events of special interest (AESIs; serious infections…