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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:
ClinicalTrials.gov Identifier:
NCT00851929
First Posted: February 26, 2009
Last Update Posted: February 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gilead Sciences
Information provided by:
Medical University of South Carolina
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851929


Contacts
Contact: Marc A Judson, MD 843-697-7272 judsonma@musc.edu
Contact: Nicole Craft 843-792-4557 craftn@musc.edu

Locations
United States, Illinois
Northwestern University Medical Center Not yet recruiting
Chicago, Illinois, United States
Contact: Peter Sporn, MD       p-sporn@northwestern.edu   
United States, North Carolina
University of North Carolina Medical Center Not yet recruiting
Chapel Hill, North Carolina, United States
Contact: James Ford, MD       hford@unch.unc.edu   
United States, South Carolina
Medical Univerrsity of South Carolina Recruiting
Charleston, South Carolina, United States, 29466
Contact: Marc A Judson, MD       judsonma@musc.edu   
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
First Submitted: February 24, 2009
First Posted: February 26, 2009
Last Update Posted: February 26, 2009
Last Verified: February 2009

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
Ambrisentan
Antihypertensive Agents