Pulmonary Arterial HypertensionPhase 4LetairisNCT02885012
Crossover Study From Macitentan or Bosentan Over to Ambrisentan
A Phase 4 study testing Ambrisentan in people with Pulmonary Arterial Hypertension, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Ambrisentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to 7 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a Connective Tissue Disease (CTD)
- Age range: 18-80 years old
- Previous Right Heart Catheterization (RHC) demonstrating PAH
- Forced vital capacity (FVC) greater than 50%
- Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
- World Health Organization (WHO) functional class II or III
Show all 11Show fewer
- Able to perform a 6 minute walk test (6MWT)
- Stable dose of antihypertensive medications
- Non-pregnant females
- Have to be currently on stable dose of bosentan for at least 3 months
- Adequate acoustic images to allow for transthoracic echocardiography to be performed
Who cannot join
- Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
- Severe systemic hypertension greater than 170/95
- Patients with a prior history of cardiovascular disease
- WHO functional class IV status
- Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
- FVC less than 50% of predicted
- DLCO less than 50% of predicted
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
Official title: A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)
The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
Read the detailed description
The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Ambrisentan
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
Also called Letairis
At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
| Study group | Role | What they receive |
|---|---|---|
| Switch to Letairis from Bosentan | Experimental | Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) Receives: Drug: Ambrisentan |
| Switch to Letairis from Macitentan | Experimental | Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis) Receives: Drug: Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stroke Volume
Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.
Measured: Baseline and 24 Weeks
Secondary outcomes (2)
Change in EmPHasis-10 Score
Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.
Measured: Baseline and 24 Weeks
Disease Status as Measured by Change in Biomarker
NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Why it stopped: Study ending due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Ochsner Health System
- Responsible party
- Sponsor
- Investigators
- Terrill Huggins, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885012
- Sponsor's protocol ID
- 00046009
- Acronym
- Letairis
- Status last verified
- Apr 2019
- First submitted
- 3 May 2016
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT02885012
- Acronym / sponsor ID
- Letairis / 00046009
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ending due to lack of enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Ochsner Health System
- Study start
- Jun 2016
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
Detailed description
The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch to Letairis from Bosentan | Experimental | Drug: AmbrisentanSubjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) |
| Switch to Letairis from Macitentan | Experimental | Drug: AmbrisentanSubjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of a Connective Tissue Disease (CTD)
- Age range: 18-80 years old
- Previous Right Heart Catheterization (RHC) demonstrating PAH
- Forced vital capacity (FVC) greater than 50%
- Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
Key exclusion criteria (7 listed)
- Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
- Severe systemic hypertension greater than 170/95
- Patients with a prior history of cardiovascular disease
- WHO functional class IV status
- Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
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: LetairisAt entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. | Drug | Switch to Letairis from Bosentan, Switch to Letairis from Macitentan |
Primary outcome
Change in Stroke Volume
Time frame: Baseline and 24 Weeks
Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.
2 secondary outcomes
Change in EmPHasis-10 Score
Time frame: Baseline and 24 Weeks
Disease Status as Measured by Change in Biomarker
Time frame: Baseline and 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Terrill Huggins, MD principal investigator
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 4 study testing Ambrisentan in people with Pulmonary Arterial 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 7 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: stopped early, as of the sponsor's last update on 8 Apr 2019. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Stroke Volume (time frame: Baseline and 24 Weeks). 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 8 Apr 2019.