Overview

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

Status:
Completed
Trial end date:
2012-07-16
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Spironolactone
Criteria
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 m2 mL/min/1.73 m2 (MDRD, Modification of Diet in Renal Disease) at the screening
visit

- Part B: 30 mL/min/1.73 m2 visit

- Serum potassium
- 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