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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01345656
First received: April 29, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Heart Failure
Drug: BAY94-8862
Drug: Placebo
Drug: Spironolactone
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of serum potassium [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in serum magnesium [ Time Frame: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: Yes ]
  • Change in blood pressure [ Time Frame: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: Yes ]
  • Change in heart rate [ Time Frame: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: Yes ]

Enrollment: 457
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY94-8862
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
Experimental: Arm 2 Drug: BAY94-8862
Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
Experimental: Arm 3 Drug: BAY94-8862
One 10 mg BAY94-8862 tablet for duration of 4 weeks
Experimental: Arm 4 Drug: BAY94-8862
Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks
Placebo Comparator: Arm 5 Drug: Placebo
Placebo tablets for duration of 4 weeks
Active Comparator: Arm 6 Drug: Spironolactone
Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
    • Part B: 30 mL/min/1.73 m2 </= eGFR <= 60 mL/min/1.73 m2 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345656

  Show 55 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01345656     History of Changes
Other Study ID Numbers: 14563, 2011-000301-45
Study First Received: April 29, 2011
Last Updated: November 4, 2013
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency

Keywords provided by Bayer:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014