BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney disease

• Conditions: Stable chronic heart failure subjects with left ventricular systolic dysfunction and mild (Part A) or moderate (Part B) chronic kidney disease; MedDRA version: 14.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000301-45-CZ
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-13
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. 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
2. 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
3. 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 -- Part B: 30 mL/min/1.73 m2 4. Serum potassium 5. Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1. Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
2. Subjects with anuria, acute renal failure, or Addison’s disease
3. Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
4. Valvular heart disease requiring surgical intervention during the course of the study
5. History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified