225
Participants
Start Date
January 11, 2017
Primary Completion Date
January 29, 2020
Study Completion Date
March 3, 2020
Riociguat (Adempas, BAY63-2521)
Film-coated tablets will be used in this study at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg. Tablets will be administered orally.The starting dose is 1 mg TID; the intervals between drug intakes should be 6 to 8 hours. The dosage should be increased by 0.5 mg increments in 2 week intervals to 1.5 mg, 2.0 mg, and 2.5 mg TID (maximal total daily dose).
Sildenafil
Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
Tadalafil
Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
Tainan City
Leuven
Graz
Aarhus N
New York
Taipei
Mineola
Prague
Berlin
Mexico City
Rochester
Hamburg
Richmond
Lübeck
Pavia
Hanover
Orlando
Weston
Istanbul
Izmir
Las Palmas de Gran Canaria
Giessen
Nashville
Louisville
Cleveland
Toledo
Troy
Detroit
Cologne
Thessaloniki
Kansas City
Homburg
Heidelberg
Dallas
Rouen
Culiacán
Napoli
München
Kaoshiung
München
Phoenix
Tucson
Palermo
Le Kremlin-Bicêtre
Sacramento
Würzburg
Newark
Belo Horizonte
Belo Horizonte
Porto Alegre
Blumenal
São Paulo
São Paulo
Montreal
Prague
Dresden
Leipzig
Chaïdári
Thessaloniki
Rome
Nagoya
Sendai
Bunkyo-ku
Amsterdam
Nijmegen
Wroclaw
Almada
Coimbra
Lisbon
Seoul
Seoul
Seoul
Seoul
Barcelona
Barcelona
Ankara
Istanbul
Clydebank
London
London
Sheffield
Lead Sponsor
Bayer
INDUSTRY