Study on the Long-term Safety and Efficacy of Ralinepag for Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called Ralinepag in patients with 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 medication being tested, Ralinepag, is taken as a prolonged-release tablet, which means it is designed to release the drug slowly over time after being taken orally.

The purpose of this study is to evaluate the long-term safety and how well patients tolerate Ralinepag. Participants in this study have previously taken part in earlier phases of research involving Ralinepag. During the study, participants will continue to take the medication and attend regular visits to monitor their health and the effects of the treatment. The study will assess various health indicators, such as levels of a specific protein in the blood, the distance a patient can walk in six minutes, and overall quality of life. These assessments help researchers understand how the medication impacts the condition over an extended period.

This study is an open-label extension, meaning that all participants will receive Ralinepag, and there is no placebo group. The study aims to provide valuable information on the long-term use of Ralinepag for managing pulmonary arterial hypertension, contributing to a better understanding of its safety and effectiveness for patients with this condition.

1 joining the study

Upon joining the study, the participant must have completed the necessary procedures from a previous study involving ralinepag.

The participant must have signed an informed consent form, indicating understanding of the study’s details.

2 medication administration

The participant will take ralinepag, which is a prolonged-release tablet, by mouth.

The dosage and frequency of the medication will be determined by the study protocol and the participant’s previous study involvement.

3 regular assessments

Throughout the study, the participant will undergo regular assessments to evaluate the effectiveness and safety of ralinepag.

These assessments include measuring NT-proBNP levels, a 6-minute walk distance test, and evaluating functional class according to WHO/NYHA standards.

4 monitoring and follow-up

The participant will be monitored for any hospitalizations or changes in health status during the study period.

A follow-up visit will occur 30 days after the last dose of ralinepag to ensure the participant’s well-being.

5 study completion

The study is estimated to conclude by December 29, 2025.

Upon completion, the participant will have contributed to understanding the long-term safety and effectiveness of ralinepag for pulmonary arterial hypertension.

Who Can Join the Study?

  • The patient must have pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs.
  • The patient must have signed and dated an Informed Consent Form, showing they understand the study details before any study-related activities begin.
  • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and complete lab tests and other study procedures.
  • The patient must have completed the necessary visits in the previous study involving the study drug, ralinepag.
  • Both male and female patients must agree to use a highly effective method of birth control during the study and for 30 days after the last dose of the study drug, if there is a chance of pregnancy.
  • Patients must agree not to try to become pregnant or cause pregnancy, donate sperm, or participate in in vitro fertilization during the study and for 30 days after the last dose of the study drug.

Who Cannot Join the Study?

  • Patients who have not participated in a previous Phase 2 or Phase 3 study of the medication called ralinepag cannot join the study.
  • Patients with medical conditions other than pulmonary arterial hypertension (PAH) are not eligible. PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are considered part of a vulnerable population, which may include groups like children, pregnant women, or those unable to give consent, may not be eligible.

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
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
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
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Germany
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
Ultojebwlb Mahfdis Chmnli Hbszcacrfngrxmxtn Hamburg Germany
Oilvdjgpgxyhkw Ltbd Ggsy Linz Austria
Dzrnqekkkv Cqfrnynpotrm Cqpduk (hlpg &zvappkhgpfq Ahwjzjhmkwq Egrm Sofia Bulgaria
Adjhwzcry Ufu Amsterdam The Netherlands
Apcgtv Uwxmlqkhja Hcpyrsjx Aarhus Denmark
Cexy De Nximt Vandoeuvre Les Nancy France
Uaaeeactue Dlyak Spuqk Dz Rchg Lq Srlwsxij Rome Italy
Coheym Hrrhxjwewa E Uzysjpltumumx Dy Cumwiuu Ebnxoe Coimbra Portugal
Hnoyheai Uvudyldwbcrfgk Sdcjpznsha &uaubel Hsctizt dt Hyjmufattnw STRASBOURG, Alsace France
Pytuixb Cvdlte Wbweqjm sus z obbt 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
13.02.2020
Belgium Belgium
Not recruiting
13.02.2020
Bulgaria Bulgaria
Not recruiting
13.02.2020
Czechia Czechia
Not recruiting
13.02.2020
Denmark Denmark
Not recruiting
13.02.2020
France France
Not recruiting
13.02.2020
Germany Germany
Not recruiting
13.02.2020
Greece Greece
Not recruiting
13.02.2020
Hungary Hungary
Not recruiting
13.02.2020
Italy Italy
Not recruiting
13.02.2020
Poland Poland
Not recruiting
13.02.2020
Portugal Portugal
Not recruiting
13.02.2020
Romania Romania
Not recruiting
13.02.2020
Spain Spain
Not recruiting
13.02.2020
The Netherlands The Netherlands
Not recruiting
13.02.2020

Trial locations

Investigated drugs:

Ralinepag (APD811): This medication is being studied for its long-term safety and effectiveness in treating pulmonary arterial hypertension (PAH). It is designed to help improve blood flow in the lungs by relaxing and widening the blood vessels, which can reduce the workload on the heart and improve symptoms in patients with PAH. Participants in this trial have previously taken part in earlier studies of this medication.

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 can progress gradually, with symptoms worsening as the pressure in the pulmonary arteries continues to rise. It is considered a rare disease and can affect individuals of any age, though it is more common in young adults. The progression of PAH can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a slower progression.

Trial ID:
2023-509305-68-00
Protocol code:
ROR-PH-303
NCT ID:
NCT03683186
Trial Phase:
Therapeutic confirmatory (Phase III)

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