Riociguat in Children With Pulmonary Arterial Hypertension (PAH)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 29, 2015

Primary Completion Date

March 7, 2020

Study Completion Date

August 3, 2027

Conditions
Hypertension, Pulmonary
Interventions
DRUG

Riociguat (Adempas, BAY63-2521)

For children with body-weight \<50 kg at screening: body-weight adjusted dose equivalent to the exposure of (0.5 mg) 1.0 - 2.5 mg three times a day, IDT in adults treated for PAH; oral suspension. For children ≥50 kg at screening: 1.0 to 2.5 mg three times a day; oral tablet.

Trial Locations (16)

1096

Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet, Budapest

6100

Hacettepe Universitesi Tip Fakultesi, Ankara

6720

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont, Szeged

13353

Deutsches Herzzentrum der Charité (DHZC), Berlin

14080

"Instituto Nacional de Cardiología Ignacio Chávez", México D.F.

35128

Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica, Padua

52763

Operadora de Hospitales Angeles S. A. de C. V., Huixquilucan

69115

Universitätsklinikum Heidelberg, Heidelberg

89075

Universitätsklinikum Ulm, Ulm

760042

Clínica Imbanaco S.A.S, Santiago de Cali

813414

Veterans General Hospital, Kaohsiung City

474-8710

Aichi Children's Health and Medical Center, Ōbu

565-0871

The University of Osaka Hospital, Suita

565-8565

National Cerebral and Cardiovascular Center, Suita

160-8582

Keio University Hospital, Shinjuku-ku

51-124

Wojewodzki Szpital Specjalistyczny - Wroclaw, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY