A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

PHASE3TerminatedINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

June 10, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Thrombocytopaenia
Interventions
DRUG

Eltrombopag

Eltrombopag will be round film-coated tablets containing eltrombopag equivalent to 50 mg (white to off-white), 200 mg and 300 mg (green) of eltrombopag free acid

DRUG

Azacitidine

Subcutaneous Injection (IV if local standard)

DRUG

Placebo

Eltrombopag matching placebo tablets

DRUG

Placebo

Eltrombopag matching placebo tablets will be supplied

Trial Locations (155)

7

Novartis Investigative Site, Dublin

8

Novartis Investigative Site, James Street

24

Novartis Investigative Site, Tallaght, Dublin

112

Novartis Investigative Site, Taipei

500

Novartis Investigative Site, Changhua

807

Novartis Investigative Site, Kaohsiung City

833

Novartis Investigative Site, Kaohsiung City

1114

Novartis Investigative Site, Buenos Aires

1140

Novartis Investigative Site, Vienna

1425

Novartis Investigative Site, Buenos Aires

2100

Novartis Investigative Site, Koebenhavn Oe

2217

Novartis Investigative Site, Kogarah

2300

Novartis Investigative Site, Turnhout

2930

Novartis Investigative Site, Brasschaat

3000

Novartis Investigative Site, Melbourne

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, East Melbourne

3010

Novartis Investigative Site, Bern

3168

Novartis Investigative Site, Clayton

4012

Novartis Investigative Site, Debrecen

4020

Novartis Investigative Site, Linz

4400

Novartis Investigative Site, Steyr

5000

Novartis Investigative Site, Adelaide

5001

Novartis Investigative Site, Aarau

6042

Novartis Investigative Site, Lodelinsart

6500

Novartis Investigative Site, Bellinzona

6725

Novartis Investigative Site, Szeged

8000

Novartis Investigative Site, Bruges

8036

Novartis Investigative Site, Graz

8091

Novartis Investigative Site, Zurich

10126

Novartis Investigative Site, Genoa

10400

Novartis Investigative Site, Bangkok

10461

Novartis Investigative Site, The Bronx

10700

Novartis Investigative Site, Bangkok

14033

Novartis Investigative Site, Caen

17007

Novartis Investigative Site, Girona

24071

Novartis Investigative Site, León

26500

Novartis Investigative Site, Pátrai

27157

Novartis Investigative Site, Winston-Salem

28007

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

28222

Novartis Investigative Site, Majadahonda (Madrid)

28223

Novartis Investigative Site, Pozuelo de Alarcon/Madrid

Novartis Investigative Site, Pozuelo de Alarcón/Madrid

29010

Novartis Investigative Site, Málaga

30322

Novartis Investigative Site, Atlanta

31096

Novartis Investigative Site, Haifa

33006

Novartis Investigative Site, Oviedo

33011

Novartis Investigative Site, Oviedo

35100

Novartis Investigative Site, Izmir

35340

Novartis Investigative Site, Izmir

37007

Novartis Investigative Site, Salamanca

37075

Novartis Investigative Site, Göttingen

38320

Novartis Investigative Site, La Laguna (Santa Cruz de Tenerife)

40225

Novartis Investigative Site, Düsseldorf

40479

Novartis Investigative Site, Düsseldorf

41124

Novartis Investigative Site, Modena

44281

Novartis Investigative Site, Kfar Saba

46010

Novartis Investigative Site, Valencia

46016

Novartis Investigative Site, Anderson

46026

Novartis Investigative Site, Valencia

47166

Novartis Investigative Site, Duisburg

49100

Novartis Investigative Site, Petah Tikva

49933

Novartis Investigative Site, Angers

50000

Novartis Investigative Site, Chiang Mai

50134

Novartis Investigative Site, Florence

53226

Novartis Investigative Site, Milwaukee

54636

Novartis Investigative Site, Thessaloniki

54642

Novartis Investigative Site, Thessaloniki

55139

Novartis Investigative Site, Samsun

58100

Novartis Investigative Site, Holon

60612

Novartis Investigative Site, Chicago

63110

Novartis Investigative Site, St Louis

64128

Novartis Investigative Site, Kansas City

64239

Novartis Investigative Site, Tel Aviv

64460

Novartis Investigative Site, Monterrey

68000

Novartis Investigative Site, Oaxaca City

70199

Novartis Investigative Site, Stuttgart

72000

Novartis Investigative Site, Le Mans

74374

Novartis Investigative Site, Pringy

75010

Novartis Investigative Site, Paris

75571

Novartis Investigative Site, Paris

81675

Novartis Investigative Site, Munich

89100

Novartis Investigative Site, Reggio Calabria

91031

Novartis Investigative Site, Jerusalem

91120

Novartis Investigative Site, Jerusalem

98108

Novartis Investigative Site, Seattle

115478

Novartis Investigative Site, Moscow

125167

Novartis Investigative Site, Moscow

129301

Novartis Investigative Site, Moscow

193024

Novartis Investigative Site, Saint Petersburg

197341

Novartis Investigative Site, St'Petersburg

248007

Novartis Investigative Site, Kaluga

440071

Novartis Investigative Site, Penza

06105

Novartis Investigative Site, Hartford

C1181ACH

Novartis Investigative Site, Buenos Aires

S3000ADL

Novartis Investigative Site, Santa Fe

A-6020

Novartis Investigative Site, Innsbruck

A-6830

Novartis Investigative Site, Rankweil

A-5020

Novartis Investigative Site, Salzburg

30130-100

Novartis Investigative Site, Belo Horizonte

81520-060

Novartis Investigative Site, Curitiba

90035-903

Novartis Investigative Site, Porto Alegre

88034-000

Novartis Investigative Site, Florianópolis

01236030

Novartis Investigative Site, São Paulo

08270-070

Novartis Investigative Site, São Paulo

20211-030

Novartis Investigative Site, Rio de Janeiro

01323-900

Novartis Investigative Site, Sao Paulo - SP

M5G 2M9

Novartis Investigative Site, Toronto

H2L 4M1

Novartis Investigative Site, Montreal

G1J 1Z4

Novartis Investigative Site, Québec

Novartis Investigative Site, Québec

J1H 5N4

Novartis Investigative Site, Sherbrooke

625 00

Novartis Investigative Site, Brno

708 52

Novartis Investigative Site, Ostrava

100 34

Novartis Investigative Site, Prague

128 08

Novartis Investigative Site, Prague

128 20

Novartis Investigative Site, Prague

8000 C

Novartis Investigative Site, Aarhus

01307

Novartis Investigative Site, Dresden

11 527

Novartis Investigative Site, Athens

41 110

Novartis Investigative Site, Larissa

Unknown

Novartis Investigative Site, Chai Wan

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Shatin, New Territories

Novartis Investigative Site, Tuenmen

Novartis Investigative Site, Galway

Novartis Investigative Site, Limerick

N-5021

Novartis Investigative Site, Bergen

0027

Novartis Investigative Site, Oslo

Lima 11

Novartis Investigative Site, Lima

Lima 31

Novartis Investigative Site, Lima

31-501

Novartis Investigative Site, Krakow

59-200

Novartis Investigative Site, Legnica

20-081

Novartis Investigative Site, Lublin

45-061

Novartis Investigative Site, Opole

76-200

Novartis Investigative Site, Słupsk

87-100

Novartis Investigative Site, Torun

00927

Novartis Investigative Site, San Juan

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

06591

Novartis Investigative Site, Seoul

135-710

Novartis Investigative Site, Seoul

137-701

Novartis Investigative Site, Seoul

138-736

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

07014

Novartis Investigative Site, Palma de Mallorca

07198

Novartis Investigative Site, Palma de Mallorca

SE-413 45

Novartis Investigative Site, Gothenburg

SE-141 86

Novartis Investigative Site, Stockholm

SE-751 85

Novartis Investigative Site, Uppsala

06590

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY