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NCT01474109 · ClinicalTrials.gov registry record · Phase 3
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 289
- Enrollment target
NCT01474109: Completed Phase 3 study, sponsored by Actelion.
NCT01474109 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 289 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01474109, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 289 participants
- Enrollment target
Study Summary
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.
Primary Outcome
DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rat
Interventions
- DRUG placebo
- DRUG macitentan 3mg
- DRUG macitentan 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01474109 record still lists
NCT01474109 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01474109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01474109 about?
NCT01474109 is a clinical study titled "Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients". 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...
What is the current status of trial NCT01474109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 289 participants. The study started on 2011-12. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01474109?
The interventions under investigation include: placebo (DRUG), macitentan 3mg (DRUG), macitentan 10mg (DRUG).
Who is sponsoring clinical trial NCT01474109?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01474109's enrollment target sits among peer trials
289 1173rd of 2000 higher than 827 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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