NCT01807221View on ClinicalTrials.gov

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

PHASE2CompletedINTERVENTIONAL
Enrollment

1,066

Participants

Timeline

Start Date

June 17, 2013

Primary Completion Date

November 11, 2014

Study Completion Date

December 9, 2014

Conditions
Heart Failure
Interventions
DRUG

Finerenone (BAY94-8862)

DRUG

Placebo

DRUG

Inspra (eplerenone)

Trial Locations (172)

220

New Taipei City

402

Taizung

1027

Budapest

1085

Budapest

1097

Budapest

1100

Vienna

1233

Sofia

1309

Sofia

1431

Sofia

2010

Darlinghurst

2100

Copenhagen Ø

2139

Concord

2400

København NV

2600

Glostrup Municipality

2650

Hvidovre

2730

Herlev

2900

Hellerup

3004

Prahran

3500

Krems

4010

Linz

4011

Stavanger

4052

Merebank

4110

Isipingo Rail

4400

Pazardzhik

Tongaat

4600

Køge

5020

Salzburg

5042

Adelaide

5700

Svendborg

6020

Innsbruck

6700

Esbjerg

6850

Worcester

7002

Rousse

7130

Somerset West

7405

Pinelands

7500

Cape Town

7580

Kuils River

8000

Székesfehérvár

8018

Burgas

8020

Graz

8036

Graz

8800

Viborg

Nagykanizsa

9010

Varna

10002

Taipei

11217

Taipei

11526

Athens

11527

Athens

12462

Chaïdári

13353

Berlin

14233

Nea Ionia / Athens

17800

Olot

20149

Milan

20520

Turku

20900

Monza Brianza

21201

Baltimore

21682

Stade

24127

Bergamo

26426

Wŏnju

28041

Madrid

28222

Majadahonda

30120

El Palmar

30625

Hanover

31201

Macon

31403

Toulouse

32209

Jacksonville

32545

Bad Oeynhausen

35100

Izmir

37099

Göttingen

41063

Mönchengladbach

41100

Larissa

45014

Fairfield

46010

Valencia

46026

Valencia

48201

Detroit

48202

Detroit

52040

Arezzo

54500

Vandœuvre-lès-Nancy

56124

Pisa

60389

Frankfurt am Main

64239

Tel Aviv

65549

Limburg an der Lahn

66421

Homburg

69677

Bron

71100

Foggia

75013

Paris

75475

Paris

76031

Rouen

90033

Los Angeles

92037

La Jolla

92288

Klaipėda

96101

Rovaniemi

97078

Würzburg

99089

Erfurt

1311001

Safed

1834111

Afula

2210001

Nahariya

3436212

Haifa

3810101

Hadera

4428164

Kfar Saba

4941492

Petah Tikva

7030000

Ẕerifin

7610001

Rehovot

7830604

Ashkelon

9103102

Jerusalem

35294-2041

Birmingham

07103

Newark

T2N 4Z6

Calgary

K1Y 4W7

Ottawa

M5B 1W8

Toronto

H1T 1C8

Montreal

H2W 1T8

Montreal

H3T 1E2

Montreal

J3A 1C3

Saint-Jean-sur-Richelieu

J1H 5N4

Sherbrooke

G1V 4G5

Québec

377 01

Jindřichův Hradec

728 80

Ostrava

150 30

Prague

274 01

Slaný

02740

Espoo

00099

Helsinki

06200

Nice

00163

Rome

06129

Perugia

LT-44320

Kaunas

LT-47144

Kaunas

LT-50161

Kaunas

LT-92288

Klaipėda

LT-08661

Vilnius

1061 AE

Amsterdam

2625 AD

Delft

9700 RB

Groningen

9728 NT

Groningen

7909 AA

Hoogeveen

6525 GA

Nijmegen

3045 PM

Rotterdam

5504 DB

Veldhoven

7207 AE

Zutphen

15-276

Bialystok

85-681

Bydgoszcz

80-952

Gdansk

40-635

Katowice

25-736

Kielce

31-121

Krakow

70-965

Szczecin

04-628

Warsaw

50-981

Wroclaw

2801-951

Almada

8000-386

Faro

1449-005

Lisbon

1500-650

Lisbon

1649-035

Lisbon

P-4200

Porto

Unknown

Petoria

Taipei

Ankara

03080

Seoul

03722

Seoul

05505

Seoul

08003

Barcelona

08035

Barcelona

791 82

Falun

416 85

Gothenburg

701 85

Örebro

118 83

Stockholm

141 86

Stockholm

182 88

Stockholm

901 85

Umeå

06100

Ankara

06500

Ankara

07003

Antalya

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01807221 - Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone | Biotech Hunter | Biotech Hunter