Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

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.
 
ClinicalTrials.gov Identifier: NCT00851929
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
Medical University of South Carolina

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Condition or disease Intervention/treatment Phase
Sarcoidosis Pulmonary Hypertension Drug: Ambrisentan Phase 2 Phase 3

Detailed Description:
Primary Endpoint: Change in 6 minute walk distance.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Study Start Date : November 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ambrisentan

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in 6 minute walk distance. [ Time Frame: 4 months of therapy ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: Marc A Judson, MD Medical University of South Carolina
Study Chair: Don C Rockey, MD Medical University of South Carolina
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Marc A. Judson, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00851929    
Other Study ID Numbers: 17747
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
sarcoidosis
pulmonary hypertension
dyspnea
sarcoidosis associated pulmonary hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Hypertension
Sarcoidosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Ambrisentan
Antihypertensive Agents