Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
