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Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis

Trial Profile

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2016

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Skin ulcer
  • Focus Registrational; Therapeutic Use
  • Acronyms DUAL-1
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 10 May 2016 Primary endpoint of incidence rate of new digital ulcers (DUs) up to Week 16 has not been met, according to Results published in the JAMA: the Journal of the American Medical Association
    • 10 May 2016 Results of DUAL-1 and DUAL-2 studies published in the JAMA: the Journal of the American Medical Association
    • 14 Aug 2014 Planned number of patients changed to 285.
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