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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 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 289 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01474109
The ClinicalTrials.gov registry entry for NCT01474109 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01474109 reports 0 study locations.
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.
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