Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

NCT00851929 | Completed Phase 2

• 1 other identifier: 17747
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sarcoidosis; Pulmonary Hypertension

Keywords

sarcoidosis; pulmonary hypertension; dyspnea; sarcoidosis associated pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Change in 6 minute walk distance.

  4 months of therapy

Study Arms (1)

sarcoidosis associated pulmonary hypertension

EXPERIMENTAL

sarcoidosis associated pulmonary hypertension

Drug: Ambrisentan

Interventions

Ambrisentan DRUG

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

Also known as: Letairis

sarcoidosis associated pulmonary hypertension

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Gilead Sciences: collaborator

Study Sites (2)

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Location

Medical Univerrsity of South Carolina

Charleston, South Carolina, 29466, United States

Location

MeSH Terms

Conditions

Sarcoidosis; Hypertension, Pulmonary; Dyspnea

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc A Judson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Don C Rockey, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 26, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

US (2)