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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...

Mise à jour : Il y a 4 ans
Référence : 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

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Extrait

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)

Critère d'inclusion

  • Erectile Dysfunction (ED)

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