Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

PHASE4CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

January 11, 2017

Primary Completion Date

January 29, 2020

Study Completion Date

March 3, 2020

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

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).

DRUG

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.

DRUG

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.

Trial Locations (81)

704

Tainan City

3000

Leuven

8036

Graz

8200

Aarhus N

10003

New York

10016

Taipei

11501

Mineola

12808

Prague

14050

Berlin

14080

Mexico City

14623

Rochester

20246

Hamburg

23225

Richmond

23538

Lübeck

27100

Pavia

30625

Hanover

32803

Orlando

33331

Weston

34093

Istanbul

34098

Izmir

35020

Las Palmas de Gran Canaria

35390

Giessen

37232

Nashville

40202

Louisville

44195

Cleveland

45004

Toledo

48085

Troy

48202

Detroit

50937

Cologne

57010

Thessaloniki

66103

Kansas City

66421

Homburg

69126

Heidelberg

75390

Dallas

76031

Rouen

80020

Culiacán

80131

Napoli

80639

München

81346

Kaoshiung

81377

München

85012

Phoenix

85724

Tucson

90127

Palermo

94270

Le Kremlin-Bicêtre

95817

Sacramento

97074

Würzburg

07112

Newark

30130-100

Belo Horizonte

30441-070

Belo Horizonte

90050-170

Porto Alegre

89030-101

Blumenal

04023-061

São Paulo

05403-000

São Paulo

H3T 1E2

Montreal

140 21

Prague

01307

Dresden

04103

Leipzig

124 62

Chaïdári

546 36

Thessaloniki

00161

Rome

467-8602

Nagoya

980-8574

Sendai

113-8655

Bunkyo-ku

1081 HV

Amsterdam

6500HB

Nijmegen

51-124

Wroclaw

2801-951

Almada

3000-075

Coimbra

1649-035

Lisbon

03722

Seoul

110-744

Seoul

135-710

Seoul

138-736

Seoul

08035

Barcelona

08036

Barcelona

06100

Ankara

34-300

Istanbul

G81 4DY

Clydebank

NW3 2QG

London

SW3 6NP

London

S10 2JF

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY