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Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone (ARTS-HF Japan)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01955694
First received: September 30, 2013
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design.

Primary objective of the study is to investigate efficacy [percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862 given once daily.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of BAY94-8862 in Japanese Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone Versus Eplerenone

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10 [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum potassium [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: November 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAY94-8862 (2.5 mg)
2.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 5 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
Drug: Placebo
matching placebo
Experimental: BAY94-8862 (5 mg)
5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 10 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
Drug: Placebo
matching placebo
Active Comparator: Eplerenone
25 mg eplerenone every other day, i.e. one 25 mg eplerenone capsule on Day 1, Day 3, Day 5, etc. in the morning, 1 placebo capsule on Day 2, Day 4, Day 6, etc. in the morning, and 1 placebo tablet once daily in the morning, with possible up-titration to 25 mg eplerenone once daily at Visit 6 (Day 30), i.e. one 25 mg eplerenone capsule once daily in the morning and 1 placebo tablet once daily in the morning, and a possible up-titration to 25 mg once daily [if not performed at Visit 6 (Day 30)] or to 50 mg once daily [if up-titrated to 25 mg once daily at Visit 6 (Day 30)] at Visit 8 (Day 60), based on the value of blood potassium
Drug: Eplerenone
INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets
Drug: Placebo
matching placebo
Experimental: BAY94-8862 (7.5 mg)
7.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 15 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: This treatment group may be introduced into the study or not after safety and tolerability of these doses has been assessed by an independent Data Monitoring Committee (DMC) (1st dose recommendation DMC meeting).
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
Drug: Placebo
matching placebo
Experimental: BAY94-8862 (10 mg)
10 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study.
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
Drug: Placebo
matching placebo
Experimental: BAY94-8862 (15 mg)
15 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study.
Drug: BAY94-8862
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
Drug: Placebo
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (IV) diuretics at hospital
  • Subjects with either type 2 DM or moderate CKD

Exclusion Criteria:

  • Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
  • Acute coronary syndrome (ACS) (elevated cardiac troponins which are not caused by an ACS are not an exclusion criterion) in the last 30 days prior to the screening visit
  • Cardiogenic shock
  • Valvular heart disease requiring surgical intervention during the course of the study
  • Subjects with left ventricular assistance device or waiting for heart transplantation
  • Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
  • Addison's disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955694

Locations
Japan
Seto, Aichi, Japan, 489-8642
Toyota, Aichi, Japan, 471-8513
Funabashi, Chiba, Japan, 273-8588
Kamogawa, Chiba, Japan, 296-0041
Kamogawa, Chiba, Japan, 296-8602
Matsuyama, Ehime, Japan, 790-0067
Chikushino, Fukuoka, Japan, 818-8516
Amagasaki, Hyogo, Japan, 660-0828
Kobe, Hyogo, Japan, 650-0047
Kobe, Hyogo, Japan, 654-0155
Higashiibaraki, Ibaraki, Japan, 311-3193
Hiratsuka, Kanagawa, Japan, 254-8502
Kawasaki, Kanagawa, Japan, 211-8533
Yokohama, Kanagawa, Japan, 245-8575
Uji, Kyoto, Japan, 611-0042
Sendai, Miyagi, Japan, 983-8520
Naha, Okinawa, Japan, 900-0005
Naha, Okinawa, Japan, 902-8511
Urasoe, Okinawa, Japan, 901-2132
Sayama, Saitama, Japan, 350-1323
Sayama, Saitama, Japan, 350-1305
Kusatsu, Shiga, Japan, 525-8585
Shinjuku-ku, Tokyo, Japan, 162-8666
Shinjuku-ku, Tokyo, Japan, 162-8655
Kofu, Yamanashi, Japan, 400-8506
Fukuoka, Japan, 810-0001
Kagoshima, Japan, 892-0853
Kyoto, Japan, 607-8062
Okayama, Japan, 700-8607
Osaka, Japan, 558-8558
Shizuoka, Japan, 420-8630
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01955694     History of Changes
Other Study ID Numbers: 16815
Study First Received: September 30, 2013
Last Updated: November 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAY94-8862
MR antagonist
Heart failure
Japanese patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Ventricular Dysfunction, Left
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Renal Insufficiency
Urologic Diseases
Ventricular Dysfunction
Eplerenone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014