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Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
Sponsor: Cumberland Pharmaceuticals
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).
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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2017-01
Completion Date
2026-05
Last Updated
2025-07-10
Healthy Volunteers
No
Conditions
Interventions
Oral Ifetroban
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Oral Placebo
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Locations (13)
The Universtity of Arizona Arthrtis Center
Tucson, Arizona, United States
UCLA
Los Angeles, California, United States
Cleveland Clinic - Florida
Weston, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hospital for Special Surgery
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Research Institute
Dallas, Texas, United States
PGIMER
Chandigarh, Chandigarh, India
KDH - Kokilaben Dhirubhai Ambani Hospital
Mumbai, Maharashtra, India
B. J. Government Medical College
Pune, Maharashtra, India