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

NCT01955694 | Completed Phase 2 DMC

• 1 other identifier: 16815
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Heart Failure

Keywords

BAY94-8862; MR antagonist; Heart failure; Japanese patients

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to 90 days

Secondary Outcomes (1)

• Change in serum potassium

  From baseline to 90 days

Study Arms (6)

BAY94-8862 (2.5 mg)

EXPERIMENTAL

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; Drug: Placebo

BAY94-8862 (5 mg)

EXPERIMENTAL

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; Drug: Placebo

Eplerenone

ACTIVE COMPARATOR

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; Drug: Placebo

BAY94-8862 (7.5 mg)

EXPERIMENTAL

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; Drug: Placebo

BAY94-8862 (10 mg)

EXPERIMENTAL

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; Drug: Placebo

BAY94-8862 (15 mg)

EXPERIMENTAL

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; Drug: Placebo

Interventions

BAY94-8862 DRUG

2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets

BAY94-8862 (10 mg); BAY94-8862 (15 mg); BAY94-8862 (2.5 mg); BAY94-8862 (5 mg); BAY94-8862 (7.5 mg)

Eplerenone DRUG

INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets

Eplerenone

Placebo DRUG

matching placebo

BAY94-8862 (10 mg); BAY94-8862 (15 mg); BAY94-8862 (2.5 mg); BAY94-8862 (5 mg); BAY94-8862 (7.5 mg); Eplerenone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (29)

Unknown Facility

Seto, Aichi-ken, 489-8642, Japan

Location

Unknown Facility

Toyota, Aichi-ken, 471-8513, Japan

Location

Unknown Facility

Funabashi, Chiba, 273-8588, Japan

Location

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Kamogawa, Chiba, 296-8602, Japan

Location

Unknown Facility

Matsuyama, Ehime, 790-0067, Japan

Location

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Chikushino-shi, Fukuoka, 818-8516, Japan

Location

Unknown Facility

Amagasaki, Hyōgo, 660-8550, Japan

Location

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Kobe, Hyōgo, 650-0047, Japan

Location

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Kobe, Hyōgo, 654-0155, Japan

Location

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Higashiibaraki, Ibaraki, 311-3193, Japan

Location

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Hiratsuka, Kanagawa, 254-8502, Japan

Location

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Kawasaki, Kanagawa, 211-8533, Japan

Location

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Yokohama, Kanagawa, 245-8575, Japan

Location

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Uji, Kyoto, 611-0041, Japan

Location

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Sendai, Miyagi, 983-8520, Japan

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Naha, Okinawa, 900-0005, Japan

Location

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Naha, Okinawa, 902-8511, Japan

Location

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Urasoe, Okinawa, 901-2132, Japan

Location

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Sayama, Saitama, 350-1305, Japan

Location

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Kusatsu, Shiga, 525-8585, Japan

Location

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Shinjuku-ku, Tokyo, 162-8655, Japan

Location

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Shinjuku-ku, Tokyo, 162-8666, Japan

Location

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Kofu, Yamanashi, 400-8506, Japan

Location

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Fukuoka, 810-0001, Japan

Location

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Kagoshima, 892-0853, Japan

Location

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Kyoto, 607-8062, Japan

Location

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Okayama, 700-8607, Japan

Location

Unknown Facility

Osaka, 558-8558, Japan

Location

Unknown Facility

Shizuoka, 420-8630, Japan

Location

Related Publications (1)

• Sato N, Ajioka M, Yamada T, Kato M, Myoishi M, Yamada T, Kim SY, Nowack C, Kolkhof P, Shiga T; ARTS-HF Japan study group. A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease. Circ J. 2016 Apr 25;80(5):1113-22. doi: 10.1253/circj.CJ-16-0122. Epub 2016 Apr 14.

  PMID: 27074824 RESULT

Related Links

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

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone; Eplerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 7, 2013
• Study Start: November 11, 2013
• Primary Completion: January 23, 2015
• Study Completion: February 20, 2015
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

JP (29)