Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00851929
• Date of registration: 24/02/2009
• Prospective Registration: No
• Primary sponsor: Medical University of South Carolina
• Public title: Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
• Scientific title: Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
• Date of first enrolment: November 2008
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00851929
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Don C Rockey, MD
• Affiliation: Medical University of South Carolina

• Name: Marc A Judson, MD
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Pulmonary Hypertension

Intervention(s)

Drug: Ambrisentan

Primary Outcome(s)

Change in 6 minute walk distance. [Time Frame: 4 months of therapy]

Secondary ID(s)

17747

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences