BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

May 9, 2011

Primary Completion Date

May 30, 2012

Study Completion Date

July 16, 2012

Conditions
Heart Failure
Interventions
DRUG

BAY94-8862

Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks

DRUG

BAY94-8862

Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks

DRUG

BAY94-8862

One 10 mg BAY94-8862 tablet for duration of 4 weeks

DRUG

BAY94-8862

Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks

DRUG

Placebo

Placebo tablets for duration of 4 weeks

DRUG

Spironolactone

Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks

Trial Locations (50)

1100

Vienna

1200

Bruxelles - Brussel

2000

Frederiksberg

2100

Copenhagen Ø

2400

København NV

2650

Hvidovre

2730

Herlev

2900

Hellerup

2930

Brasschaat

4010

Linz

4600

Køge

5000

Odense

5700

Svendborg

6700

Esbjerg

8036

Graz

8800

Roeselare

Viborg

12808

Prague

13353

Berlin

15030

Prague

22880

Wedel

29185

Kristianstad

50968

Cologne

60596

Frankfurt am Main

64239

Tel Aviv

99084

Erfurt

1311001

Safed

1834111

Afula

3810101

Hadera

4941492

Petah Tikva

7610001

Rehovot

7830604

Ashkelon

625 00

Brno

460 63

Liberec

FIN-00260

Helsinki

FI-40620

Jyväskylä

FIN-20520

Turku

01277

Dresden

04779

Wermsdorf

0450

Oslo

Unknown

Stavanger

Stockholm

30-082

Krakow

97-635

Piotrkow Trybunalski

70-965

Szczecin

04-635

Warsaw

50-981

Wroclaw

222 21

Lund

111 35

Stockholm

118 83

Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY