Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02682511
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2016-02-08
Brief Title:
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis SSc or SSc-associated Pulmonary Arterial Hypertension
Sponsor:
Cumberland Pharmaceuticals
Organization:
Cumberland Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis SSc or SSc-associated Pulmonary Arterial Hypertension SSc-PAH
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The purpose of this phase 2 multicenter randomized double-blind placebo-controlled study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc dcSSc or SSc-associated pulmonary arterial hypertension SSc-PAH
Detailed Description:
This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc or SSc-PAH Twenty participants with SSc-PAH and 14 participants with dcSSc will be randomized to receive either oral ifetroban daily or matching placebo Study participants will be treated for 12 months followed by a 30-day follow-up period The study will test whether ifetroban is safe and statistically superior to placebo in reducing the effects of their disease at month 12 and explore the ability of ifetroban to prevent or reverse progression in patients with early disease duration and reverse established disease in patients with longer disease duration
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