A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease.
Phase of Trial: Phase III
Latest Information Update: 07 Oct 2017
At a glance
- Drugs Collagenase clostridium histolyticum (Primary)
- Indications Peyronie's disease
- Focus Registrational; Therapeutic Use
- Acronyms IMPRESS-I
- Sponsors Auxilium Pharmaceuticals
- 19 May 2015 Results presented at the American Urological Association (AUA) at its 110th Annual Scientific Meeting, as reported by Endo Pharmaceuticals media release.
- 30 Jan 2015 According to a Swedish Orphan Biovitrum AB media release, the EU Commission has approved Xiapex for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
- 08 May 2014 According to a BioSpecifics Technologies Corporation media release, a MAA of XIAPEX for the treatment of Peyronie's disease is being processed by SOBI (Swedish Orphan Biovitrium AB).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History