check_circleStudy Completed

Heart Failure

Bayer Identifier:

14563

ClinicalTrials.gov Identifier:

NCT01345656

EudraCT Number:

2011-000301-45

EU CT Number:

Not Available
BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney disease

Trial purpose

A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
    - Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
    - Known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
     -- Part A: 60 mL/min/1.73 m*2  -- Part B: 30 mL/min/1.73 m*2 - Serum potassium - Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit
  • - Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
    - Subjects with anuria, acute renal failure, or Addison’s disease
    - Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
    - Valvular heart disease requiring surgical intervention during the course of the study
    - History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment

Trial summary

Enrollment Goal
457
Trial Dates
May 2011 - July 2012
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Wroclaw, 50-981, Poland
Completed
Helsinki, FIN-00260, Finland
Completed
Turku, FIN-20520, Finland
Completed
Jyväskylä, FI-40620, Finland
Completed
Stavanger, Norway
Completed
Oslo, 0450, Norway
Withdrawn
Düsseldorf, 40217, Germany
Completed
Frankfurt, 60596, Germany
Completed
Köln, 50968, Germany
Withdrawn
Dortmund, 44139, Germany
Completed
Wedel, 22880, Germany
Completed
Krakow, 30-082, Poland
Completed
Stockholm, 111 35, Sweden
Completed
Lund, 222 21, Sweden
Completed
Kristianstad, 29185, Sweden
Completed
Copenhagen Ø, 2100, Denmark
Completed
Hellerup, 2900, Denmark
Completed
København NV, 2400, Denmark
Completed
Hvidovre, 2650, Denmark
Completed
Herlev, 2730, Denmark
Completed
Svendborg, 5700, Denmark
Completed
Odense, 5000, Denmark
Completed
Zefat, 1311001, Israel
Completed
Ashkelon, 7830604, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Rehovot, 7610001, Israel
Completed
Graz, 8036, Austria
Withdrawn
Feldkirch, 6807, Austria
Completed
Wien, 1100, Austria
Withdrawn
Salzburg, 5020, Austria
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn
LEUVEN, 3000, Belgium
Completed
Warszawa, 04-635, Poland
Completed
Piotrkow Trybunalski, 97-635, Poland
Completed
Szczecin, 70-965, Poland
Completed
Stockholm, Sweden
Completed
Linz, 4010, Austria
Completed
Brno, 625 00, Czechia
Completed
Praha 2, 12808, Czechia
Completed
Praha 5, 15030, Czechia
Completed
Liberec, 460 63, Czechia
Completed
BRASSCHAAT, 2930, Belgium
Completed
ROESELARE, 8800, Belgium
Completed
Erfurt, 99084, Germany
Completed
Køge, 4600, Denmark
Completed
Berlin, 13353, Germany
Completed
Hadera, 3810101, Israel
Completed
Tel Aviv, 64239, Israel
Completed
Afula, 1834111, Israel
Completed
Berlin, 13353, Germany
Completed
Wermsdorf, 04779, Germany
Completed
Dresden, 01277, Germany
Completed
Stockholm, 118 83, Sweden
Completed
Frederiksberg, 2000, Denmark
Completed
Viborg, 8800, Denmark
Completed
Esbjerg, 6700, Denmark

Primary Outcome

  • Change of serum potassium
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change in serum magnesium
    date_rangeTime Frame:
    Day 8, Day 15, Day 22, Day 29
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in blood pressure
    date_rangeTime Frame:
    Day 8, Day 15, Day 22, Day 29
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in heart rate
    date_rangeTime Frame:
    Day 8, Day 15, Day 22, Day 29
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A randomized, double-blind, multi-center study to assess safety and tolerability of different oral doses of BAY94-8862 in subjects with stable chronic heart failure with left ventricular systolic dysfunction and mild (Part A) or moderate (Part B) chronic kidney disease versus placebo (Part A) or versus placebo and spironolactone (Part B)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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