Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

289

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Systemic SclerosisUlcers
Interventions
DRUG

macitentan 3mg

macitentan 3mg tablet once daily

DRUG

macitentan 10mg

macitentan 10mg tablet once daily

DRUG

placebo

matching placebo once daily

Trial Locations (77)

1023

Budai Irgalmasrendi Kórház, Budapest

1612

"MHAT Sv. Ivan Rilski EAD Sofia - Clinic of Rheumatology", Sofia

2050

Royal Prince Alfred Hospital, Camperdown

2400

Bispebjerg Hospital København, Copenhagen

3065

St Vincent's Hospital, Fitzroy

4002

"MHAT Kaspela EOOD Plovdiv - Rheumatology Ward", Plovdiv

4032

Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Debrecen

4066

Wesley Hospital, Thoracic Department, Auchenflower

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense

5800

"Multiprofile Hospital for Active Treatment Sveti Pantaleymon", Pleven

7000

Menzies Research Institute, Hobart

7632

Pécsi Tudományegyetem Klinikai Központ, Reumatológiai és Immunológiai Klinika, Pécs

10000

"Klinicka Bolnica Svety Duh", Zagreb

Klinička bolnica Dubrava, Zagreb

University Hospital Centre Zagreb, Zagreb

10117

Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie, Berlin

12000

Revmatologický ústav Praha, Prague

12206

The Center for Rheumatology, Albany

15261

University of Pittsburgh Department of Rheumatology, Pittsburgh

16635

Altoona Center for Clinical Research, Duncansville

21000

Klinički bolnički centar Split, Split

22559

Asklepios Westklinikum Hamburg Abteilung für Gefäßmedizin, Angiologie und Diabetologie, Hamburg

22763

Rheumatologie, klinische Immunologie, Nephrologie Asklepios Rheumazentrum Hamburg Asklepios Klinik Altona, Hamburg

31000

Klinicki Bolnicki Centar Osijek, Osijek

33180

Arthritis & Rheumatic Disease Specialties, Aventura

34239

Sarasota Arthritis Research Center, Sarasota

36039

Internal disease chair of Ukrainian medical dentist academy based on therapy department of Poltava Poltava City Clinical Hospital #1, Poltava

41100

Azienda Ospedaliera Policlinico di Modena, Modena

44195

The Cleveland Clinic Foundation, Cleveland

44791

Klinik für Dermatologie und Allergologie der Ruhr-Universität Bochum, Bochum

48109

University of Michigan - Scleroderma Program, Ann Arbor

49005

Dinpropetrovsk Regional Clinical Hospital named after I. Mechnykova, Dnipropetrovsk

49546

Michigan State University, Grand Rapids

50139

Azienda Ospedaliera Careggi, Florence

50937

Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln, Cologne

51000

University Hospital Centre Rijeka, Rijeka

62500

Lekarna FN Brno, Brno

70121

Ochsner Medical Center, New Orleans

72076

Universitäts-Hautklinik Tübingen, Tübingen

76307

Akademie für Gefäßkrankheiten eV., Karlsbad

79010

Lviv Regional Clinical Hospital, Lviv

79106

Medizinische Universitätsklinik Freiburg, Abt. Rheumatologie und klinische Forschung, Freiburg im Breisgau

85724

University of Arizona Arthritis Center, Tucson

90095

UCLA Medical School - Rheumatology Division Rehabilitation Center, Los Angeles

220013

"Healthcare Institution Minsk City Hospital #1", Minsk

220116

"Healthcare Institution Minsk Clinical Hospital #9", Minsk

246029

Gomel Regional Clinical Hospital, Homyel

440026

"State Healthcare Institution Penza Regional Clinical Hospital named after N.N. Burdenko", Penza

500082

Advance Rheumatology Clinic, Hyderabad

600023

"Vladimir Regional State Institution of Healthcare, Regional Clinical Hospital", Vladimir

620102

"State Healthcare Institution Sverdlovsk Regional Clinical Hospital #1", Yekaterinburg

632004

Christian Medical College, Vellore

2570017

Centro de Estudios Clinicos V, Viña del Mar

7510047

Prosalud, Santiago

7510186

Private Office Marta Aliste, Santiago

8500000

Hospital San Juan de Dios, Santiago

21224-6801

The Johns Hopkins University School of Medicine, Baltimore

08903-0010

University of Medicine & Dentistry of New Jersey, UMDNJ Scleroderma Program, New Brunswick

27617-7884

Shanahan Rheumatology and Immunotherapy, PLLC, Raleigh

29425-8905

Medical University of South Carolina, Charleston

T5M 0H4

Rheumatology Research Associates, Edmonton

V6Z 1Y6

St. Paul's Hospital, Vancouver

N6A 4V2

St. Joseph's Health Care, London

M5G 1X5

Mount Sinai Hospital, Toronto

J1H 5N4

CHUS Hopital Fleurimont, Sherbrooke

Unknown

Medicity S.A.S., Bucaramanga

Servimed E.U., Bucaramanga

500 05

Faculty Hospital Hradec Králové, Hradec Králové

00290

Helsingin yliopistollinen keskussairaala (HYKS), Meilahden kolmiosairaala, Reumatologian klinikka, Helsinki

500 003

Krishna Institute of Medical Sciences, Secunderabad

00168

Complesso Integrato Columbus, Rome

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

20-607

NZOZ Reumed, Lublin

02-507

Centralny Szpital Kliniczny MSWiA, Warsaw

50-566

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wroclaw

04107

Municipal Institution of Kyiv Regional Council, Kyiv Regional Clinical Hospital, Kyiv

Sponsors

Lead Sponsor

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