Study on the Effectiveness and Safety of Ralinepag for Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying a condition known as pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study is evaluating a treatment called Ralinepag, which is taken as a prolonged-release tablet. This means the medication is designed to release slowly into the body over time. The purpose of the study is to understand how effective and safe Ralinepag is in improving treatment outcomes for patients with PAH.

Participants in the study will be randomly assigned to receive either Ralinepag or a placebo, which looks like the medication but does not contain the active substance. The study will monitor the time it takes for participants to experience a worsening of their condition, as defined by the study’s guidelines. This will help researchers determine the effectiveness of Ralinepag in delaying the progression of PAH. The study will also look at other factors, such as changes in exercise capacity and overall health status, to gather comprehensive data on the treatment’s impact.

The study will last for a period of up to 48 weeks, during which participants will have regular check-ups and assessments to track their health and any changes in their condition. This will include various tests and evaluations to ensure the safety and effectiveness of the treatment. The information gathered from this study will contribute to a better understanding of how Ralinepag can be used to manage PAH and improve the quality of life for those affected by this condition.

1 Joining the study

Upon joining the study, the participant will be informed about all relevant aspects of the trial. This includes understanding the purpose, procedures, and potential risks and benefits.

The participant must provide a signed and dated informed consent form before any study-related procedures begin.

2 Initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of pulmonary arterial hypertension (PAH) and ensuring the participant meets all inclusion criteria.

A right heart catheterization (RHC) may be performed if not done within the last three years to confirm the PAH diagnosis.

3 Randomization and treatment

Participants will be randomly assigned to receive either ralinepag or a placebo. Ralinepag is administered as a prolonged-release tablet taken orally.

The dosage and frequency of administration will be determined by the study protocol and communicated to the participant.

4 Regular follow-up visits

Participants will attend scheduled follow-up visits to monitor their health and response to the treatment. These visits will include physical examinations, laboratory tests, and assessments of PAH symptoms.

Participants are expected to comply with the treatment plan and attend all scheduled visits.

5 Monitoring and data collection

Throughout the study, data will be collected on the participant’s health status, including any clinical worsening events, hospitalizations, and overall treatment outcomes.

Participants may be asked to complete questionnaires or undergo additional tests to assess their quality of life and functional status.

6 End of study

The study will conclude on the estimated end date, or earlier if necessary. Participants will have a final visit to assess their health and discuss any further steps.

A follow-up visit may be scheduled 30 days after the last dose of the study medication to ensure the participant’s well-being.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Both men and women must agree to use a highly effective method of birth control during the study and for a period after the study ends, if they can have children. They must also agree not to try to become pregnant or father a child during the study and for a certain time after the last dose of the study medication. Men must also agree not to donate sperm for a period after the last dose.
  • Must have signed an Informed Consent Form, which means they understand the important details of the study before any study-related activities begin.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and complete laboratory tests and other study procedures.
  • Must have a primary diagnosis of symptomatic pulmonary arterial hypertension (PAH), which is a type of high blood pressure affecting the lungs and heart. This can be due to various causes, such as being idiopathic (unknown cause), inherited, or caused by drugs, toxins, or other conditions like connective tissue disease or HIV infection.
  • Must have had a right heart catheterization (RHC), a test to check the pressure in the heart and lungs, within the last 3 years or be willing to have one during the study screening. The results must confirm the diagnosis of PAH.
  • Must have symptoms classified as WHO/NYHA functional class II to IV, which describes the severity of symptoms and how they affect daily activities.
  • If taking specific PAH medications, must be on a stable dose of these medications for at least 30 days before starting the study and continue this stable dose throughout the study. These medications include endothelin receptor antagonists (ERA), PDE5 inhibitors, or soluble guanylate cyclase (sGC) stimulators. If taking a PDE5 inhibitor for erectile dysfunction, it is allowed up to 3 times a week.
  • Must be able to walk at least 150 meters in a 6-minute walk distance (6MWD) test, which measures how far a person can walk in 6 minutes.
  • If taking other medications that might affect PAH symptoms, such as calcium channel blockers, diuretics, digoxin, L-arginine supplements, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers, the dose must be stable for at least 30 days before starting the study and remain stable during the study. Diuretics must be stable for at least 10 days before starting the study.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
MHAT National Heart Hospital EAD Sofia Bulgaria
Hospital Universitario 12 De Octubre Madrid Spain
Gottsegen National Cardiovascular Center Budapest Hungary
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Onassis Cardiac Surgery Center Kallithea Greece
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest Romania
Institutul Inimii De Urgenta Pentru Boli Cardiovasculare Niculae Stancioiu Cluj Napoca Romania
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Germany
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Saarland University Hospital Homburg Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Institutul De Pneumoftiziologie Marius Nasta Bucharest Romania
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Rigshospitalet Copenhagen Denmark
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. Palermo Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
University Of Szeged Szeged Hungary
Uqgzaatadn Mbfxopx Caizte Hdtcsodzglecknnjj Hamburg Germany
Owpzgrsvksuzqn Lock Gksl Linz Austria
Drkvxttscg Cfroeqqkxuvd Cmskew (dvid &qztfwruxleb Aphaqcyehtz Ebrd Sofia Bulgaria
Anwqcvzlf Uak Amsterdam The Netherlands
Arewkm Udbaulptim Hqnplwhq Aarhus Denmark
Ckir Ds Noeyv Vandoeuvre Les Nancy France
Ugkpzipbjf Dylis Selzz Dc Rpbs Lm Srpbfpnu Rome Italy
Idokuqps dc Csrnfkbqpojt Hzdjdaykcbw Uzgvfzkgogbwe do Snfcb Eywoolp (qnvmjaf Saint Priest En Jarez France
Hckvjsit Uimuzllraltwbp Sfvwrhofor &otjufj Hkngdxz db Hmhexjejpzw STRASBOURG, Alsace France
Ptubkdl Cwlejx Wqsmsii ssq z obhc Wroclaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
19.07.2019
Belgium Belgium
Not recruiting
19.07.2019
Bulgaria Bulgaria
Not recruiting
19.07.2019
Czechia Czechia
Not recruiting
19.07.2019
Denmark Denmark
Not recruiting
19.07.2019
France France
Not recruiting
19.07.2019
Germany Germany
Not recruiting
19.07.2019
Greece Greece
Not recruiting
19.07.2019
Hungary Hungary
Not recruiting
19.07.2019
Italy Italy
Not recruiting
19.07.2019
Poland Poland
Not recruiting
19.07.2019
Portugal Portugal
Not recruiting
19.07.2019
Romania Romania
Not recruiting
19.07.2019
Spain Spain
Not recruiting
19.07.2019
The Netherlands The Netherlands
Not recruiting
19.07.2019

Trial locations

Investigated drugs:

Ralinepag is a medication being studied for its potential to improve treatment outcomes in patients with pulmonary arterial hypertension (PAH). The main goal of the study is to see how well ralinepag can delay the time until a patient’s condition worsens according to specific criteria set by the study.

Pulmonary Arterial Hypertension (PAH) – Pulmonary arterial hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the heart may become enlarged and weakened due to the increased workload. The disease progresses as the blood vessels in the lungs become more narrowed or blocked, further increasing the pressure. This can lead to a reduced ability to exercise and perform daily activities. As the condition advances, it may cause complications affecting the heart and other organs.

Trial ID:
2023-509304-16-00
Protocol code:
ROR-PH-301
NCT ID:
NCT03626688
Trial Phase:
Therapeutic confirmatory (Phase III)

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