SarcoidosisPhase 2/3NCT00851929
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
A Phase 2/3 study testing Ambrisentan in people with Sarcoidosis and Pulmonary Hypertension, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sarcoidosis, Pulmonary Hypertension
- What is being tested?
- Ambrisentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Nov 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina Medical Center
Chapel Hill, North Carolina
Medical Univerrsity of South Carolina
Charleston, South Carolina, 29466
About this study
Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Read the detailed description
Primary Endpoint: Change in 6 minute walk distance.
- Conditions
- Sarcoidosis, Pulmonary Hypertension
- Being tested
- Ambrisentan
- Keywords
- sarcoidosis, pulmonary hypertension, dyspnea, sarcoidosis associated pulmonary hypertension
- Medical subject headings
- Sarcoidosis, Hypertension, Pulmonary, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
Also called Letairis
ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months
| Study group | Role | What they receive |
|---|---|---|
| sarcoidosis associated pulmonary hypertension | Experimental | sarcoidosis associated pulmonary hypertension Receives: Drug: Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk distance.
Measured: 4 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Investigators
- Marc A Judson, MD, Principal investigator, Medical University of South CarolinaDon C Rockey, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851929
- Sponsor's protocol ID
- 17747
- Status last verified
- Jul 2018
- First submitted
- 24 Feb 2009
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00851929
- Acronym / sponsor ID
- 17747
- Conditions
- Sarcoidosis, Pulmonary Hypertension
- Keywords
- sarcoidosis, pulmonary hypertension, dyspnea, sarcoidosis associated pulmonary hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sarcoidosis associated pulmonary hypertension | Experimental | Drug: Ambrisentansarcoidosis associated pulmonary hypertension |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmbrisentanAlso: Letairisambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months | Drug | sarcoidosis associated pulmonary hypertension |
Primary outcome
Change in 6 minute walk distance.
Time frame: 4 months of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A Judson, MD principal investigator
Medical University of South Carolina
Don C Rockey, MD study chair
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ambrisentan in people with Sarcoidosis and Pulmonary Hypertension, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minute walk distance. (time frame: 4 months of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.