Status:
COMPLETED
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
Lead Sponsor:
Actelion
Conditions:
Digital Ulcers
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. Th...
Eligibility Criteria
Inclusion
- Main
- Systemic Sclerosis (SSc), diffuse or limited.
- SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.
- Main
Exclusion
- Digital ulcers due to conditions other than SSc.
- Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
- Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
- Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
- Treatment with inhaled or oral prostanoids one month prior to randomization.
- Previous treatment with bosentan.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00077584
Start Date
October 1 2003
End Date
May 1 2005
Last Update
February 3 2025
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