Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT00851929

Collaborator

Gilead Sciences (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis Pulmonary Hypertension	Drug: Ambrisentan	Phase 2/Phase 3

Detailed Description

Primary Endpoint: Change in 6 minute walk distance.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sarcoidosis associated pulmonary hypertension sarcoidosis associated pulmonary hypertension	Drug: Ambrisentan ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months Other Names: Letairis

Arm

Intervention/Treatment

Experimental: sarcoidosis associated pulmonary hypertension

sarcoidosis associated pulmonary hypertension

Drug: Ambrisentan

ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months

Other Names:

Letairis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina Medical Center	Chapel Hill	North Carolina	United States
2	Medical Univerrsity of South Carolina	Charleston	South Carolina	United States	29466