Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Completed · Phase 2/Phase 3

Conditions studied: Sarcoidosis, Pulmonary Hypertension

In brief

Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Key facts

Study ID

NCT00851929

Run by

Medical University of South Carolina

People needed

16

Starts

2008-11-01

Expected to finish

2011-11-01

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven sarcoidosis
• Mean pulmonary artery pressure > 25 mmHg at rest and greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
• Pulmonary capillary wedge pressure ≤ 15 mmHg
• PVR values >3.0 Woods units
• Forced vital capacity (FVC) >40%
• WHO functional class II or III
• Stable sarcoidosis treatment regimen for three months prior to entry into study
• 6 minute walk distance between 150-450 meters
• Stable dose of antihypertensive medications
• On no other medication to treat PAH (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study
• Non-pregnant females

You may not qualify if…

• Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
• Severe systemic hypertension > 170/95
• Patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction
• Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
• Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, etc.)
• Use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).
• WHO functional class IV status
• Patients with significant left ventricular dysfunction
• Significant liver dysfunction not due to sarcoidosis.
• Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.

Where it is running

• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Medical Univerrsity of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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