Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05179876
PHASE3

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

Sponsor: Actelion

View on ClinicalTrials.gov

Summary

The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

Official title: A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2022-05-04

Completion Date

2028-02-29

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Macitentan

Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (\>=) 2 year to less than (\<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.

DRUG

Selexipag

Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of \>=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight \< 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.

DRUG

Macitentan/Tadalafil FDC

Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.

Locations (43)

The Republican Scientific-Practical Center ''Cardiology''

Minsk, Belarus

Minsk Regional Clinical Hospital Of The Red Banner Of Labor

Minsk, Belarus

UZ Leuven

Leuven, Belgium

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

Sofia, Bulgaria

Beijing Anzhen Hospital

Beijing, China

The Second Xiangya Hospital of Central South Hospital

Changsha, China

Jiangsu Province Hospital

Nanjing, China

Qingdao Women and Children's Hospital

Qingdao, China

Childrens Hospital of Shanghai

Shanghai, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Gottsegen György Országos Kardiológiai Intézet

Budapest, Hungary

Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku

Bialystok, Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

Bydgoszcz, Poland

SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca

Katowice, Poland

Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego

Lodz, Poland

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

Lublin, Poland

SPSK2 PUM Klinika Kardiologii

Szczecin, Poland

Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy

Wroclaw, Poland

Wojewodzki Szpital Specjalistyczny we Wroclawiu

Wroclaw, Poland

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

Kemerovo, Russia

E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

Novosibirsk, Russia

Federal State Budgetary Institution

Saint Petersburg, Russia

Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences

Tomsk, Russia

Regional Clinical Hospital No1

Tyumen, Russia

Abdullah, IA

Durban, South Africa

Dr Kalla

Lenasia, South Africa

Chungnam National University Hospital

Daejeon, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, Taiwan

Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

Chiang Mai, Thailand

Municipal Inst. Of Dnipropetrovsk Region. Council

Dnipro, Ukraine

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Kyiv, Ukraine

Hanoi Heart Hospital

Hanoi, Vietnam

Hanoi Medical University Hospital

Hanoi, Vietnam

Children's Hospital 1

Ho Chi Minh City, Vietnam