Placebo Controlled Trial of Bosentan in Scleroderma Patients

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Scleroderma, Pulmonary Hypertension

In brief

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

Key facts

Study ID

NCT00377455

Run by

Georgetown University

People needed

5

Starts

2006-09-01

Expected to finish

2010-03-01

Last updated by the study team

2018-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Established resting pulmonary hypertension
• Congestive heart failure
• Diastolic dysfunction
• Pregnancy
• Inability to adequately walk/exercise
• Severe liver disease

Where it is running

• University of Connecticut — Farmington, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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