Conditions: Digital Ulcers
Keywords: digital ulcers systemic sclerosis finger ulcers bosentan open label
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 116
Healthy volunteers: no

Brief summary:
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

Detailed description:

Arms:
arm 1: Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter

Interventions: intervention 1: Bosentan 62.5 mg intervention 2: Bosentan 125 mg
Intervention descriptions: intervention 1: Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose) intervention 2: Bosentan 125-mg oral tablets administered b.i.d. (target dose)

Protocol document: