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

NCT ID: NCT01955694

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-11
• Study Completion Date: 2015-02-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

BAY94-8862

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

matching placebo

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

Group Type: EXPERIMENTAL

BAY94-8862

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

matching placebo

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

Group Type: ACTIVE_COMPARATOR

Eplerenone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

matching placebo

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).

Group Type: EXPERIMENTAL

BAY94-8862

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

matching placebo

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.

Group Type: EXPERIMENTAL

BAY94-8862

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

matching placebo

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.

Group Type: EXPERIMENTAL

BAY94-8862

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

matching placebo

Interventions

BAY94-8862

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

Intervention Type: DRUG

Eplerenone

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

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Seto, Aichi-ken, Japan

Toyota, Aichi-ken, Japan

Funabashi, Chiba, Japan

Kamogawa, Chiba, Japan

Matsuyama, Ehime, Japan

Chikushino-shi, Fukuoka, Japan

Amagasaki, Hyōgo, Japan

Kobe, Hyōgo, Japan

Kobe, Hyōgo, Japan

Higashiibaraki, Ibaraki, Japan

Hiratsuka, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Uji, Kyoto, Japan

Sendai, Miyagi, Japan

Naha, Okinawa, Japan

Naha, Okinawa, Japan

Urasoe, Okinawa, Japan

Sayama, Saitama, Japan

Kusatsu, Shiga, Japan

Shinjuku-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Kofu, Yamanashi, Japan

Fukuoka, , Japan

Kagoshima, , Japan

Kyoto, , Japan

Okayama, , Japan

Osaka, , Japan

Shizuoka, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 27074824 (View on PubMed)

Related Links

http://clinicaltrials.bayer.com/

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Other Identifiers

16815

Identifier Type: -

Identifier Source: org_study_id