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
Price :
$35
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At a glance
- Drugs Macitentan (Primary)
- Indications Skin ulcer
- Focus Registrational; Therapeutic Use
- Acronyms DUAL-1
- Sponsors Actelion Pharmaceuticals
- 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.