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Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Medical University of South Carolina.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00851929
First received: February 24, 2009
Last updated: February 25, 2009
Last verified: February 2009
  Purpose
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Condition Intervention Phase
Sarcoidosis
Pulmonary Hypertension
Drug: Ambrisentan
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Change in 6 minute walk distance. [ Time Frame: 4 months of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: November 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Letairis

Detailed Description:

Primary Endpoint: Change in 6 minute walk distance.

Secondary Endpoints:

  • Safety

    • Oxygen saturation at rest and with exercise
    • Hospitalization
    • Mortality
  • WHO functional class
  • Quality of life as measured by

    • Short-form 36
    • Sarcoidosis Health Questionnaire
  • Dyspnea as measured by

    • Borg Dyspnea Index
    • St. George Respiratory Questionnaire
  • Sarcoidosis activity as measured by the

    • STAI sarcoidosis instrument (33)
    • Prednisone dose
  • Pulmonary function

    • Forced vital capacity (FVC)
    • Diffusion (DLCO)
  • Endothelin-1 levels

    • Bronchoalveolar lavage
    • Plasma
  • B-type natruetic peptide
  • Inflammatory and fibrotic mediators (IL-2, IL-6, IL-12, IL-18, IL-23, TNF-α) in BALF
  • Compliance with treatment
  • Time to clinical worsening (defined by the initiation of ambrisentan treatment to the first occurrence of death, lung transplantation, hospitalization for pulmonary arterial hypertension, arterial septostomy, a change in chronic prostanoid or sildenafil treatment due to protocol defined worsening criteria or study withdrawal due to additional of other clinically approved PAH therapeutic agents)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851929

Locations
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States
United States, North Carolina
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
United States, South Carolina
Medical Univerrsity of South Carolina
Charleston, South Carolina, United States, 29466
Sponsors and Collaborators
Medical University of South Carolina
Gilead Sciences
  More Information

Responsible Party: Marc A. Judson, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00851929     History of Changes
Other Study ID Numbers: 17747 
Study First Received: February 24, 2009
Last Updated: February 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
sarcoidosis
pulmonary hypertension
dyspnea
sarcoidosis associated pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Sarcoidosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on December 06, 2016