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Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Primary Purpose

Sarcoidosis, Pulmonary Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ambrisentan
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring sarcoidosis, pulmonary hypertension, dyspnea, sarcoidosis associated pulmonary hypertension

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina Medical Center
  • Medical Univerrsity of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sarcoidosis associated pulmonary hypertension

Arm Description

sarcoidosis associated pulmonary hypertension

Outcomes

Primary Outcome Measures

Change in 6 minute walk distance.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2009
Last Updated
July 31, 2018
Sponsor
Medical University of South Carolina
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00851929
Brief Title
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Official Title
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Pulmonary Hypertension
Keywords
sarcoidosis, pulmonary hypertension, dyspnea, sarcoidosis associated pulmonary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sarcoidosis associated pulmonary hypertension
Arm Type
Experimental
Arm Description
sarcoidosis associated pulmonary hypertension
Intervention Type
Drug
Intervention Name(s)
Ambrisentan
Other Intervention Name(s)
Letairis
Intervention Description
ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months
Primary Outcome Measure Information:
Title
Change in 6 minute walk distance.
Time Frame
4 months of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Judson, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Don C Rockey, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Medical Univerrsity of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29466
Country
United States

12. IPD Sharing Statement

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Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

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