Long-term Safety Study of Tadalafil and Macitentan for Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

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What is this study about?

This clinical trial is focused on studying the long-term safety of treatments for two types of lung conditions: pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. These conditions involve high blood pressure in the lungs, which can lead to serious health issues. The study will use a combination of medications, including a drug with the code name JNJ-68150420, which contains the active substances tadalafil and macitentan. Additionally, the study will involve the use of Opsumit, which contains macitentan as its active ingredient.

The purpose of this study is to evaluate the long-term safety of these treatments in participants who have been using them in previous studies. Participants will take the medications in the form of film-coated tablets, which are taken orally. The study will follow participants over a period of time to monitor their health and any potential side effects that may occur while using these treatments.

Throughout the study, participants will be regularly monitored to ensure their safety and to gather information on how the treatments affect their condition. This will help researchers understand the long-term effects of these medications and provide valuable information for future treatment options for people with these lung conditions.

1 joining the study

Upon joining the study, the participant will begin by taking part in a long-term follow-up study. This study is designed to monitor the safety of the treatments being used for pulmonary hypertension.

The participant will be required to sign an informed consent form, indicating an understanding of the study’s purpose and procedures.

2 medication administration

Participants will continue taking the medications they were using in the previous study. These include macitentan and a fixed-dose combination of macitentan 10 mg and tadalafil 40 mg, both administered orally.

The medication is provided in the form of film-coated tablets.

3 monitoring and follow-up

Participants will be monitored for any adverse effects that may arise from the treatment. This includes tracking any new symptoms or changes in health status.

Regular follow-up appointments will be scheduled to assess the participant’s response to the treatment and to ensure their safety.

4 safety assessments

The study will evaluate the frequency of any adverse events, including serious adverse events or any that lead to discontinuation of the treatment.

Participants will be required to undergo regular health assessments to ensure the continued safety of the treatment.

5 end of study

The study is expected to conclude by December 13, 2027. Participants will be informed of the study’s outcomes and any necessary follow-up actions at this time.

Who Can Join the Study?

The participant must sign an informed consent form, which is a document that shows they understand the study and agree to take part. If the participant is under 18, their parent(s) must sign, and the child must also agree if they are old enough to understand.
The participant must have been treated with the study medication (macitentan, selexipag, or a fixed-dose combination of macitentan and tadalafil) at the end of a previous related study.
The participant must have completed the previous study related to the current study.
No other way to access the study medication or a similar approved treatment should be available to the participant.
The participant should still benefit from continuing the study medication.
For children, the participant must be at least 2 years old.
A female participant who can have children must have a negative pregnancy test before starting the study medication.
The female participant must agree to take a pregnancy test every month until the end of the study’s safety follow-up period.
The female participant must agree to use birth control methods as defined in the study guidelines until 30 days after the last dose of the study medication.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name	City	Country
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Gottsegen National Cardiovascular Center	Budapest	Hungary
Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw	Poland
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie	Lublin	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Snbanxk Kspzknonf Ivu Knbuex Juhjazwfp Ukhoanrtihfr Mxqvevoujn Ijc Kdryjf Mcaaptkcaslbzdb W Pnlydbrw	Poznan	Poland
Ufasjzfzthwag Sdjobte Kpebtifkz Nw 2 Pdr W Sgelnqpmrb	Szczecin	Poland
Duktcydamj Cyzfehpnlvkm Cshyxp (xral &hrunowcfshs Aopqjtqfgks Ebsp	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	04.05.2022
Hungary	Recruiting	04.05.2022
Poland	Recruiting	04.05.2022

Trial locations

Investigated drugs:

Study Intervention: This refers to the specific treatment or medication being tested in the clinical trial for pulmonary hypertension. The study aims to observe the long-term safety of this intervention in participants who have been using it in previous related studies. The exact name of the medication or therapy is not provided, but it is the main focus of the trial to ensure its safety over an extended period.

Investigated diseases:

Pulmonary hypertension

Pulmonary Arterial Hypertension – This is a condition where the blood pressure in the arteries of the lungs is higher than normal. It occurs when the small arteries in the lungs become narrowed or blocked, making it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through these arteries. Over time, this increased workload can lead to the weakening of the heart muscle. Symptoms often include shortness of breath, fatigue, and dizziness. The disease can progress gradually, with symptoms worsening over time.

Chronic Thromboembolic Pulmonary Hypertension – This condition arises when blood clots obstruct the blood vessels in the lungs, leading to increased blood pressure in these vessels. It is a form of pulmonary hypertension that persists after a blood clot in the lung, known as a pulmonary embolism, has resolved. The obstruction of blood flow causes the heart to work harder to push blood through the lungs. Over time, this can lead to heart strain and reduced oxygen levels in the blood. Symptoms may include shortness of breath, fatigue, and chest pain. The condition can develop slowly, with symptoms becoming more pronounced as the disease progresses.

Trial ID:

2023-506791-27-00

Protocol code:

NOPRODPAPUH3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Long-term Safety Study of Tadalafil and Macitentan for Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

What is this study about?

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