Mobile

Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind...

Update Il y a 4 ans
Reference: EUCTR2008-000536-40

Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I

  • | Country :
    • -
  • | organs :
    • -
  • | Specialty :
    • -

Extract

The primary objective of this study is to compare the efficacy and safety of vardenafil ODT 10 mg (PRN) after 12 weeks of treatment or LOCF with placebo in a general population of men with erectile dysfunction. In this study, 50% of the men on active treatment have to be 65 years-of-age or older. Primary efficacy variables are: - IIEF-EF Domain score at visit 4 (week 12) or LOCF - SEP 2 (success rates of penetration) and SEP 3 (maintenance of erection) at visit 4 (week 12) overall (co-primary variable)

Inclusion criteria

  • Erectile Dysfunction (ED)

Links