Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Public ClinicalTrials.gov record NCT01474109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. Other objectives include: * the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. * the evaluation of the safety and tolerability of macitentan in these patients. * the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.
Study identification
- NCT ID
- NCT01474109
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 289 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2011
- Primary completion
- Oct 31, 2013
- Completion
- Oct 31, 2013
- Last update posted
- Jan 5, 2015
2011 – 2013
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Arthritis Center | Tucson | Arizona | 85724 | — |
| UCLA Medical School - Rheumatology Division Rehabilitation Center | Los Angeles | California | 90095 | — |
| Arthritis & Rheumatic Disease Specialties | Aventura | Florida | 33180 | — |
| Sarasota Arthritis Research Center | Sarasota | Florida | 34239 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | 21224-6801 | — |
| University of Michigan - Scleroderma Program | Ann Arbor | Michigan | 48109 | — |
| Michigan State University | Grand Rapids | Michigan | 49546 | — |
| University of Medicine & Dentistry of New Jersey, UMDNJ Scleroderma Program | New Brunswick | New Jersey | 08903-0010 | — |
| The Center for Rheumatology | Albany | New York | 12206 | — |
| Shanahan Rheumatology and Immunotherapy, PLLC | Raleigh | North Carolina | 27617-7884 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| University of Pittsburgh Department of Rheumatology | Pittsburgh | Pennsylvania | 15261 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425-8905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01474109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2015 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01474109 live on ClinicalTrials.gov.