A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
This research is looking at a new treatment called HS235 for adults with Pulmonary Arterial Hypertension (PAH). PAH is a serious lung condition where blood pressure in the arteries leading to the lungs becomes too high. The study wants to find out if HS235 is safe, what effects it has on the body, and if it can help people feel better when used alongside their current PAH medications. Some participants will receive HS235, while others will get a placebo (a dummy drug with no active ingredients). This is a 'Phase 1b/2' study, meaning it's an early-stage trial that first checks safety and then looks for signs of effectiveness and the right dose. Participants will be carefully monitored throughout.
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¿De qué trata este estudio?
This study is about a new medication called HS235 for adults who have a specific type of high blood pressure in the lungs, known as Pulmonary Arterial Hypertension (PAH). PAH makes it harder for the heart to pump blood through the lungs, causing symptoms like breathlessness and tiredness.
The main goal of this research is to see if HS235 is safe for people with PAH and how their bodies react to it. It also aims to find out if this new drug can help improve their health and symptoms when added to the treatments they are already taking. Some people in the study will receive HS235, while others will be given a placebo (a substance that looks like the drug but has no active ingredients) to compare the effects fairly.
This is an important step in finding new ways to treat PAH. By understanding how HS235 works and if it helps, researchers hope to develop better treatments for people living with this condition.
Puntos clave
- This study tests a new drug, HS235, for adults with Pulmonary Arterial Hypertension (PAH).
- It aims to check safety, how the drug works, and if it helps improve health.
- Participants will receive either HS235 or a placebo, alongside their usual PAH medicines.
- Close medical monitoring will be provided throughout your participation.
- La participación es voluntaria, y puedes retirarte en cualquier momento.
- This is an early-stage study, so potential benefits and risks are still being evaluated.
¿Quién puede ser elegible?
To join this study, you must be an adult aged 18 or older. You should have been diagnosed with a specific type of high blood pressure in your lungs called WHO Group 1 Pulmonary Arterial Hypertension (PAH) and be experiencing symptoms. You also need to be taking at least two approved medications for your PAH, plus diuretics (water pills), and these treatments should be stable.
There are also some physical requirements, such as a certain body weight and a minimum walking distance you can cover in six minutes. Doctors will also check specific measurements related to your lung blood pressure during screening tests. You must be able to attend all study appointments and follow the study instructions carefully.
However, you cannot join if you have other types of high blood pressure in the lungs (Groups 2, 3, 4, or 5), or if you've been in hospital recently for a serious medical issue or surgery. Certain heart conditions, kidney problems, liver problems, or a history of stroke in the last 90 days would also mean you couldn't take part. You also can't have participated in a previous study using a similar type of drug.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Eres un adulto de 18 años o más?
- Do you have WHO Group 1 Pulmonary Arterial Hypertension (PAH)?
- Are you currently taking at least two approved PAH medications and diuretics?
- Can you attend regular study visits and follow instructions?
- Have you *not* had any major surgery or hospitalisation in the last 4 weeks?
- Have you *not* had a stroke in the last 90 days or certain other heart/lung conditions?
¿En qué consiste la participación?
If you decide to take part, you would first go through a screening process to check if the study is right for you. This involves medical exams, tests, and discussions about your health. If you qualify, you will be randomly assigned to either receive the new medication, HS235, or a placebo, which looks identical but contains no active drug. Neither you nor your study doctor will know which one you are receiving – this is to ensure the results are fair and unbiased.
You will continue to take your usual PAH medications throughout the study. You will have regular visits to the study clinic where the research team will monitor your health, check for any side effects, and perform various tests. These tests might include blood samples, physical examinations, and possibly more walking tests to see how the treatment is affecting you. The total duration of your involvement in the study, including the follow-up, will be explained fully by the study team.
Riesgos y beneficios potenciales
Ubicaciones (7)
- Investigational Site-102Código postal verificadoTampa, Estados Unidos· Reclutamiento
- Investigational Site-101Código postal verificadoBoston, Estados Unidos· Reclutamiento
- Investigational Site-104Código postal verificadoProvidence, United States· Reclutamiento
- Investigational Site-305Código postal verificadoBarcelona, España· Reclutamiento
- Investigational Site- 301Código postal verificadoBarcelona, España· Reclutamiento
- Investigational Site-308Código postal verificadoMadrid, España· Reclutamiento
- Investigational Site-903Código postal verificadoLondres, Reino Unido· Reclutamiento
Preguntas comunes
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a serious condition where the blood vessels in the lungs become narrow, causing high blood pressure in the arteries leading from the heart to the lungs. This makes the heart work harder and can cause breathlessness and tiredness.
¿Qué es un 'placebo'?
A placebo is a 'dummy' treatment that looks exactly like the actual study medication but contains no active drug. It's used in studies to fairly compare the effects of the new medication.
What does 'randomized, double-blind' mean?
It means participants are randomly chosen to receive either the study drug or the placebo. 'Double-blind' means neither you nor your study doctor will know which treatment you are getting, to keep the study fair.
Will I have to stop my current PAH medications?
No, you will continue to take your usual PAH medications throughout the study. HS235, or the placebo, will be added to your current treatment plan.
¿Cuánto tiempo estaré en el estudio?
The study team will provide you with full details on the expected duration of your participation, including all follow-up appointments, during your initial consultation.
Cómo obtener más información
US GSK Clinical Trials Call Center
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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