Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851929

Enrollment

Registered

2009-02-26

Start date

2008-11-30

Completion date

2011-11-30

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension, Sarcoidosis

Keywords

sarcoidosis, pulmonary hypertension, dyspnea, sarcoidosis associated pulmonary hypertension

Brief summary

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

Detailed description

Primary Endpoint: Change in 6 minute walk distance.

Interventions

DRUGAmbrisentan

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in 6 minute walk distance.	4 months of therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026