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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: BAY94-8862 (Drug); BAY94-8862 (Drug); BAY94-8862 (Drug); BAY94-8862 (Drug); Placebo (Drug); Spironolactone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change of serum potassium

Secondary outcome:

Change in serum magnesium

Change in blood pressure

Change in heart rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Salzburg 5020, Austria

Wien 1100, Austria

Brasschaat 2930, Belgium

Bruxelles - Brussel 1200, Belgium

Leuven 3000, Belgium

Roeselare 8800, Belgium

Brno 625 00, Czech Republic

Liberec 460 63, Czech Republic

Praha 2 12808, Czech Republic

Praha 5 15030, Czech Republic

Copenhagen Ø 2100, Denmark

Esbjerg 6700, Denmark

Frederiksberg 2000, Denmark

Hellerup 2900, Denmark

Herlev 2730, Denmark

Hvidovre 2650, Denmark

København NV 2400, Denmark

Køge 4600, Denmark

Odense 5000, Denmark

Svendborg 5700, Denmark

Viborg 8800, Denmark

Helsinki FIN-00260, Finland

Jyväskylä FI-40620, Finland

Turku FIN-20520, Finland

Berlin 13353, Germany

Afula 18101, Israel

Ashkelon 78278, Israel

Hadera 38100, Israel

Petach Tikva 49100, Israel

Rehovot 76100, Israel

Safed 13100, Israel

Tel Aviv 64239, Israel

Oslo 0450, Norway

Stavanger, Norway

Krakow 30-082, Poland

Piotrkow Trybunalski 97-635, Poland

Szczecin 70-965, Poland

Warszawa 04-635, Poland

Wroclaw 50-981, Poland

Kristianstad 29185, Sweden

Lund 222 21, Sweden

Stockholm 111 35, Sweden

Stockholm 118 83, Sweden

Stockholm, Sweden

Frankfurt, Hessen 60594, Germany

Dortmund, Nordrhein-Westfalen 44139, Germany

Düsseldorf, Nordrhein-Westfalen 40217, Germany

Köln, Nordrhein-Westfalen 50968, Germany

Linz, Oberösterreich 4010, Austria

Dresden, Sachsen 01277, Germany

Wermsdorf, Sachsen 04779, Germany

Wedel, Schleswig-Holstein 22880, Germany

Graz, Steiermark 8036, Austria

Erfurt, Thüringen 99084, Germany

Feldkirch, Vorarlberg 6807, Austria

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Click here to find results for studies related to Bayer Healthcare products

Starting date: May 2011
Last updated: May 21, 2015

Page last updated: August 23, 2015

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