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A Phase 3, Open-label 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

Trial Profile

A Phase 3, Open-label 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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Sep 2020

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At a glance

  • Drugs Collagenase clostridium histolyticum (Primary)
  • Indications Peyronie's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms IMPRESS
  • Sponsors Auxilium Pharmaceuticals
  • Most Recent Events

    • 04 Sep 2020 Results of post hoc analysis from NCT02298829, NCT01221597, NCT01221623, NCT01243411 and NCT01685437 determoning the long-term (5 year) efficacy and safety profile of CCH in men subgrouped by the degree of penile plaque calcification prior to treatment, published in the Urology
    • 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.
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