Trials / Completed
CompletedNCT00319696
Bosentan in Digital Ulcers
Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan 62.5 mg | Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose) |
| DRUG | Bosentan 125 mg | Bosentan 125-mg oral tablets administered b.i.d. (target dose) |
Timeline
- Start date
- 2004-07-08
- Primary completion
- 2009-01-22
- Completion
- 2009-01-22
- First posted
- 2006-04-27
- Last updated
- 2025-02-04
- Results posted
- 2012-08-08
Source: ClinicalTrials.gov record NCT00319696. Inclusion in this directory is not an endorsement.