Status:
COMPLETED
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Lead Sponsor:
Actelion
Conditions:
Systemic Sclerosis
Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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. I...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Patients ≥ 18 years of age
- Women of childbearing potential must use two reliable methods of contraception
- Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR)
- At least one visible, active ischemic digital ulcers (DU) at baseline
- History of at least one additional recent active ischemic DU
- Exclusion Criteria :
- DUs due to condition other than SSc
- Symptomatic Pulmonary arterial hypertension (PAH)
- Body mass index (BMI) \< 18 kg/m\^2
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 x upper limit of the normal range (ULN)
- Hemoglobin \< 75% of the lower limit of the normal range
- Systolic blood pressure \< 95 mmHg or diastolic blood pressure \< 50 mmHg
- Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition.
- Females who are pregnant or breastfeeding or plan to do so during the course of this study.
- Substance or alcohol abuse or dependence, or tobacco use at any level.
- Treatment with phosphodiesterase type-5 (PDE5) inhibitors.
- Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period.
- Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period.
- Treatment with prostanoids within 3 months.
- Treatment with disease modifying agents if present for less than 3 months prior to Screening or whose treatment has not been stable for at least 1 month prior to Screening.
- Treatment with oral corticosteroids (\> 10 mg/day of prednisone or equivalent).
- Treatment with ERAs within 3 months.
- Systemic antibiotics to treat infected DU(s) within 4 weeks.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01474109
Start Date
December 1 2011
End Date
November 1 2013
Last Update
January 6 2015
Active Locations (77)
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1
University of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
2
UCLA Medical School - Rheumatology Division Rehabilitation Center
Los Angeles, California, United States, 90095
3
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
4
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239