Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

PHASE2CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

January 15, 2015

Primary Completion Date

December 15, 2017

Study Completion Date

March 28, 2019

Conditions
Scleroderma, Systemic
Interventions
DRUG

Riociguat (Adempas, BAY63-2521)

Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID

DRUG

Placebo

Sham-titration

Trial Locations (59)

1200

CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel

2170

Liverpool Hospital, Liverpool

3000

UZ Leuven Gasthuisberg, Leuven

3065

St Vincent's Hospital, Fitzroy

3168

Monash Medical Centre, Clayton

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5000

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth

6021

Wellington Hospital, Wellington

7632

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

8091

UniversitätsSpital Zürich, Zurich

9000

UZ Gent, Ghent

9007

Kantonsspital St. Gallen, Sankt Gallen

20007

Georgetown University Medical Center, Washington D.C.

29425

Medical University of South Carolina Medical Center, Charleston

33000

Hôpital Pellegrin - Bordeaux, Bordeaux

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

35128

A.O. di Padova, Padua

35340

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

38043

Centre Hospitalier Universitaire - Grenoble, Grenoble

48109

University of Michigan Health System, Ann Arbor

50139

A.O.U. Careggi, Florence

50937

Universitätsklinikum Köln, Cologne

56126

A.O.U. Pisana, Pisa

59037

Hopital Claude-Huriez CHRU, Lille

61231

Kerckhoff-Klinik GmbH, Bad Nauheim

67098

CHU STRASBOURG - Hôpital de Hautepierre, Strasbourg

75674

Cochin - Paris, Paris

77030

Memorial Hermann-Texas Medical Center, Houston

84132

University of Utah Health Care, Salt Lake City

89081

Universitätsklinikum Ulm, Ulm

91054

Universitätsklinikum Erlangen, Erlangen

94304

Stanford University School of Medicine, Palo Alto

85259-5404

Mayo Clinic - Scottsdale, Scottsdale

90095-1670

UCLA David Geffen School of Medicine, Los Angeles

06030

University of Connecticut Health Center, Farmington

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

L8N 1Y2

St. Joseph's Healthcare - Hamilton, Hamilton

L3Y 3R7

Arthritis Program Research Group, Inc., Newmarket

M5T 3L9

Mount Sinai Hospital, Toronto

H3T1E2

Sir Mortimer B. Davis Jewish General Hospital, Montreal

128 50

Revmatologicky ustav, Prague

00161

A.O.U. Policlinico Umberto I, Rome

09042

A.O.U. di Cagliari, Cagliari

371-8511

Gunma University Hospital, Maebashi

060-8648

Hokkaido University Hospital, Sapporo

980-8574

Tohoku University Hospital, Sendai

113-8603

Nippon Medical School Hospital, Bunkyo-ku

162-0054

Institute of Rheumatology Tokyo Women's Medical University, Shinjuku-ku

6525 GA

Universitair Medisch Centrum St. Radboud, Nijmegen

3584 CX

University Medical Center Utrecht, Utrecht

Unknown

Universitätsspital Basel, Basel

Hacettepe Universitesi Tip Fakultesi, Ankara

01330

Cukurova Univ. Tip. Fak. Balcali Hastanesi, Adana

M6 8HD

Hope Hospital, Salford

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

DD1 9SY

Ninewells Hospital, Dundee

L9 7AL

Aintree University Hospital, Liverpool

NW3 2QG

Royal Free Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY