Research offers a different path for PAH patients
People living with pulmonary arterial hypertension (PAH) often struggle with activities that once took little-to-no effort. Simple things, like playing with your dog or bringing in the groceries, may now cause you to stop and catch your breath.
As part of this study, medical professionals will provide study-related monitoring of your PAH and overall health.
About PAH
Pulmonary arterial hypertension (PAH) is a type of high blood pressure that affects arteries in the lungs. Symptoms of PAH may include shortness of breath, fatigue, dizziness or fainting, and chest pressure or pain.
Although progress has been made in developing medications for PAH, many people are still affected by the disease. As a result, there is still a need for medications that can help treat and slow the progression of the disease.
Who is eligible to be in the UNISUS Study?
To pre-qualify for this study, you must be:
Bt least 18 years of age, and
Diagnosed with PAH
All study-required visits, tests, and medications will be provided at no cost. In addition, reimbursement for study-required travel may be available.
About the UNISUS Study
The UNISUS research study is dedicated to people with PAH. The study will compare the effectiveness and safety of a higher dose of an investigational medication against a lower dose.
The investigational medication has been approved by regulatory agencies in many countries around the world at a lower dosage to treat PAH. The doctors conducting the research want to learn more about the safety and effectiveness of the investigational medication at a higher dosage that has not been approved in any country for any condition. This higher dose is currently being studied in people with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (CTEPH).
The results of the UNISUS study will provide more information about the investigational medication’s effectiveness and safety when it is given at a higher dose to adults with PAH.
What is my role in the study as a participant?
If you are eligible and agree to be in this study, you will be randomly assigned (by chance) to receive either the higher or lower dose of the investigational medication as well as a matching placebo. A placebo looks like the investigational medication and is given in the same manner but does not have any active medication. You have an equal chance of being assigned to receive either dose of the investigational medication. If you are currently taking medicine to treat your PAH, you may be able to continue taking it while in the study.
Neither you, the study doctor, or the study staff will know which study medication dose you’ll be receiving. However, in case of an emergency, that information can be provided to your study doctor.
You will take 2 tablets (study medication + placebo) once a day as instructed by the study doctor while you are in the study.
After completing the treatment period, you will continue into the treatment extension period which will consist of two phases. During the first phase, you will receive either a higher or lower dose of the investigational medication along with a matching placebo for 4 weeks. During the last phase called the open-label phase, all participants will have the option to receive the higher, target dose of the investigational medication.
Your total study participation may last 3 to 6 years. During your study participation, you will be asked to attend regular study clinic visits to evaluate your health. You will also receive phone calls from the study staff to discuss the study and check in on how you are feeling.
What are the potential benefits and risks related to the UNISUS study?
While it’s possible your PAH could improve as a participant in this study, that cannot be guaranteed. However, your study participation may help people with PAH in the future.
It is possible that you could experience one or more side effects during this study. Before you begin the study, the study doctor will talk you through the potential study-related risks and side effects.
This study has been approved by an independent review board that is responsible for patient safety. Because participation in this study could affect your health, you will be closely monitored throughout the study. Study researchers designed a protocol that explains the study in detail, and the protocol must be followed exactly as written.
For additional information about clinical studies please see the FAQ section.
Short Study Summary
Medical condition
Pulmonary Arterial Hypertension (PAH)
Study Duration
3 to 6 years
Locations
This is a global study which will enroll approximately 900 participants across North America, South America, Europe, and Asia-Pacific.
Phase
3
Frequently Asked Questions
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.
Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).
All new medical treatments and drugs have gone through clinical trials to make sure that they are safe and effective.
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.
Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).
All new medical treatments and drugs have gone through clinical trials to make sure that they are safe and effective.
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.
Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.
Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).