Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01474109
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2011-10-31
Brief Title:
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Sponsor:
Actelion
Organization:
Actelion
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUAL-1
Brief 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 111 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
Patients will be randomized in a 111 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
Detailed Description:
Recurrent digital ulcers DU are a manifestation of vascular disease in patients with systemic sclerosis SSc are an important source of morbidity and lead to impaired function in these patients In this study we are investigating whether treatment with the endothelin receptor antagonist macitentan decreases the development of new digital ulcers in patients with SSc Macitentan is a highly potent tissue-targeting dual endothelin receptor antagonist Through complete blockade of endothelin action macitentan is expected to protect tissue from the damaging effect of elevated endothelin This therapy is not approved for the treatment of systemic sclerosis but the use of an ERA is an attractive approach in combating the structural vascular damage observed in SSc leading to complications such as DUs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None