Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077584
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2004-02-10
Brief Title:
Efficacy and Safety of Oral Bosentan on HealingPrevention of Digital Finger Ulcers in Patients With Scleroderma
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
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
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPIDS-2
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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None