Status:
TERMINATED
Placebo Controlled Trial of Bosentan in Scleroderma Patients
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Actelion
Conditions:
Systemic Scleroderma
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.
Detailed Description
Pulmonary hypertension (PAH) is a common and usually fatal form of lung disease in systemic sclerosis (SSc). Multiple drugs have been approved for the treatment of New York Heart Association (NYHA)Cla...
Eligibility Criteria
Inclusion
- SSc patients \> 18 with NYHA functional Class I/II symptoms, informed consent, and who are willing to participate in the Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma (PHAROS) long term study (Georgetown IRB 04-227)
- Right heart catheterization with
- Normal Mean Pulmonary Arterial Pressure (PAP) at rest
- Mean PAP \> 30 with exercise
- Wedge Pressure \< 18
- Entry criteria for participating in the exercise echocardiogram study (Georegtown IRB 03-363)
- Diffusing Capacity (DLCO) \<60 with a Forced Vital Capacity (FVC) \>60%, or
- FVC/DLCO \> 1.6, or
- a resting Pulmonary Arterial Systolic Pressure (PASP)\> 40mmHg
Exclusion
- Established resting pulmonary hypertension
- Congestive heart failure
- Diastolic dysfunction
- Pregnancy
- Inability to adequately walk/exercise
- Severe liver disease
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00377455
Start Date
September 1 2006
End Date
March 1 2010
Last Update
May 24 2018
Active Locations (2)
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1
University of Connecticut
Farmington, Connecticut, United States, 06030
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007