Ambrisentan (Letairis) for Sarcoidosis… | Clinical Trial

Key information

Conditions

Sarcoidosis Cardiovascular Diseases Dyspnea Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Hypertension Hypertension, Pulmonary Immune System Diseases Lung Diseases Lymphatic Diseases Lymphoproliferative Disorders Pathological Conditions, Signs and Symptoms Pulmonary Hypertension Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of North Carolina Medical Center, Chapel Hill, North Carolina, United States

About this study

Primary Endpoint: Change in 6 minute walk distance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambrisentan

Drug

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

Other names: Letairis

Primary outcomes

Change in 6 minute walk distance.

Time frame: 4 months of therapy

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

Gilead Sciences

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 26, 2009
Registry last updated: Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed