The ELEVATE Studies are clinical research studies for adults diagnosed with Pulmonary Arterial Hypertension (PAH) who are already receiving treatment for their PAH. The study medication is called rodatristat ethyl. The ELEVATE 2 Study is now enrolling patients. For physicians and others who would like more details about the ELEVATE 2 Study, please visit www.ClinicalTrials.gov.
ELEVATE 2 Study
The ELEVATE 2 Study will help researchers understand if rodatristat ethyl, an investigative oral medicine, is safe and effective when used with a patient’s usual medicines for the treatment of their PAH.
Rodatristat ethyl, the ELEVATE Studies medicine, has the potential to be a new way to treat PAH. Given by mouth as a tablet, rodatristat ethyl uses a process called tryptophan hydroxylase (TPH) inhibition to reduce the amount of serotonin in the body.
Why focus on reducing serotonin? Research has shown that increased levels of serotonin in the body can play a role in the development of PAH.
Serotonin is a substance that occurs naturally in your body. It is mainly found in your brain and digestive tract and appears to affect and/or control a number of body functions. It is thought that too much serotonin in the body may cause arteries in the lungs to narrow.
Doctors hope the ELEVATE Studies medicine, rodatristat
ethyl, can reduce the
amount of serotonin affecting the lung arteries, which may open the arteries to
allow blood to flow more easily.
Artery of person with PAH
Who is Eligible to Join?
The ELEVATE 2 Study will enroll men and women around the world, ages 18 and older. There are requirements for joining the study to make sure participants stay safe.
Requirements to join the study include the following:
- Confirmed diagnosis of PAH by right heart cardiac catherization
- Agree to undergo six-minute walk distance tests
- Have been taking other PAH medicines for at least three months
People with PAH will not be able to participate in the study if they:
- Are currently taking a monoamine oxidase inhibitor (MAOI)
- Have long QT syndrome
- Have other factors the study team can review with you
The study team will look at several other factors that will determine if you are eligible to take part in ELEVATE 2 Study.
Talk to your doctor to see if the ELEVATE 2 Study is an option for you. Your doctor knows you and your medical history and can help you find out if this study is right for you. When you talk to your doctor about the study, it is helpful to bring someone with you who can help take notes and ask questions.
The ELEVATE Studies are sponsored by Altavant Sciences (Altavant), a clinical stage biopharmaceutical company formed to advance promising therapies that treat rare respiratory diseases with an initial therapeutic focus on PAH. To learn more about Altavant, visit www.altavant.com.
Frequently Asked Questions About the ELEVATE 2 Study
Where is the ELEVATE 2 Study taking place?
Study centers are opening at medical centers globally. Ask your doctor for more information.
How do I join the ELEVATE 2 Study?
Talk to your doctor to see if the ELEVATE 2 Study is an option
for you. Your doctor knows you and your medical history and can help you find
out if this study is right for you.
Will I be given a placebo in the ELEVATE 2 Study?
In the ELEVATE 2 Study, which is a randomized study, you will
continue your current PAH medications and will be assigned to receive either
the investigative medicine or placebo by chance.
Do I have to pay to join the ELEVATE 2 Study?
No, there is no cost to join the ELEVATE 2 Study. The study medicine (rodatristat ethyl or placebo), study visits, study-related tests and study-related procedures will be provided at no cost to you. However, care that may be considered ‘routine’ may be billed to you or your insurance provider. Routine care is care you would receive regardless of whether you participate in the study or not. The study sponsor, Altavant, is providing study participants with a modest stipend for participation related expenses. Reimbursement for travel may be available.