Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Medical University of South Carolina.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical University of South Carolina
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
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 May 19, 2013