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

Inclusion Criteria:

• 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 </= eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
  • Part B: 30 mL/min/1.73 m*2 </= eGFR <= 60 mL/min/1.73 m*2 (MDRD) at the screening visit

• Serum potassium </= 4.8 mmol/L at the screening visit

• Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit

Exclusion Criteria:

• 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

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.