Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

PHASE2TerminatedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

June 4, 2014

Primary Completion Date

May 5, 2016

Study Completion Date

September 14, 2016

Conditions
Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
Interventions
DRUG

Riociguat (Adempas, BAY63-2521)

Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being.

DRUG

Placebo

Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks

Trial Locations (93)

1051

Auckland

1205

Geneva

1426

Buenos Aires

2010

Darlinghurst

2050

Camperdown

2751

Sydney

3000

Leuven

3010

Bern

3181

Prahran

4000

San Miguel de Tucumán

4032

Chermside

4200

Porto

5000

Adelaide

5501

Godoy Cruz

6150

Murdoch

8011

Christchurch

8091

Zurich

8200

Aarhus N

10032

Columbia University Medical Center, New York

11211

Riyadh

11461

Riyadh

11525

Riyadh

11527

Athens

12462

Haidari

13915

Marseille

15213

Pittsburgh

20070

Denizli

20900

Monza-Brianza

22042

Falls Church

22927

Großhansdorf

27710

Durham

30625

Hanover

32803

Orlando

33136

Miami

35100

Izmir

35392

Giessen

40202

Louisville

43221

Columbus

44195

Cleveland

45219

Cincinnati

45239

Essen

45500

Ioannina

46014

Valencia

47121

Forlì-Cesena

53100

Siena

59037

Lille

67208

Via Christi Clinic, Wichita

69500

Bron

75908

Paris

80045

Aurora

80539

München

81377

München

90024

University of California, Los Angeles, Los Angeles

90127

Palermo

91120

Jerusalem

94143

San Francisco

97074

Würzburg

97213

Portland

105077

Moscow

107564

Moscow

197022

Saint Petersburg

600023

Vladimir

3436212

Haifa

4941492

Petah Tikva

5262000

Ramat Gan

37232-5735

Nashville

75235-3858

Dallas

Unknown

Mar del Plata

Bogotá

Floridablanca-Bucaramanga

Santiago de Cali

Bogotá

C1280AEB

Buenos Aires

V5Z 1M9

Vancouver

K1Y 4W7

Ottawa

M5G 2N2

Toronto

G1V 4G5

Québec

01307

Dresden

570 10

Thessaloniki

00133

Rome

489-8642

Seto

236-0051

Yokohama

591-8555

Sakai

151-8528

Shibuya-ku

260-8677

Chiba

3000-075

Coimbra

4434-502

Vila Nova de Gaia

08003

Barcelona

08036

Barcelona

CB23 3RE

Cambridge

G81 4DY

Clydebank

SW3 6NP

London

NE7 7DN

Newcastle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02138825 - Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP) | Biotech Hunter | Biotech Hunter