Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851929
• Other study ID #: 17747
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2008
• Est. completion date: November 2011

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Primary Endpoint: Change in 6 minute walk distance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Sarcoidosis

Intervention

Drug:
• Ambrisentan
ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months

Locations

Country	Name	City	State
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Medical Univerrsity of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minute walk distance.		4 months of therapy