Trials / Completed
CompletedNCT00077584
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan 62.5 mg | Oral tablets containing 62.5 mg of bosentan |
| DRUG | Bosentan 125 mg | Oral tablets containing 125 mg of bosentan |
| DRUG | Placebo | Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets |
Timeline
- Start date
- 2003-10-01
- Primary completion
- 2005-03-01
- Completion
- 2005-05-01
- First posted
- 2004-02-11
- Last updated
- 2025-02-03
Source: ClinicalTrials.gov record NCT00077584. Inclusion in this directory is not an endorsement.