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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

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 26, 2009
Last Update Posted Date August 2, 2018
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
Change in 6 minute walk distance. [ Time Frame: 4 months of therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Official Title  ICMJE Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Brief Summary Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Detailed Description Primary Endpoint: Change in 6 minute walk distance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoidosis
  • Pulmonary Hypertension
Intervention  ICMJE Drug: Ambrisentan
ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months
Other Name: Letairis
Study Arms  ICMJE Experimental: sarcoidosis associated pulmonary hypertension
sarcoidosis associated pulmonary hypertension
Intervention: Drug: Ambrisentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2009)
24
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851929
Other Study ID Numbers  ICMJE 17747
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc A. Judson, M.D., Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Marc A Judson, MD Medical University of South Carolina
Study Chair: Don C Rockey, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP