--- title: Phase IIb Safety and Efficacy Study of Different Oral Doses 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 Chronic Kidney Disease Alone nct_id: NCT01807221 overall_status: COMPLETED phase: PHASE2 sponsor: Bayer study_type: INTERVENTIONAL primary_condition: Heart Failure countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye) canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01807221.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01807221" ct_last_update_post_date: 2021-07-06 last_seen_at: "2026-05-12T07:26:49.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Phase IIb Safety and Efficacy Study of Different Oral Doses 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 Chronic Kidney Disease Alone **Official Title:** A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in 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 Chronic Kidney Disease Alone Versus Eplerenone **NCT ID:** [NCT01807221](https://clinicaltrials.gov/study/NCT01807221) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 1066 - **Lead Sponsor:** Bayer - **Conditions:** Heart Failure - **Start Date:** 2013-06-17 - **Completion Date:** 2014-12-09 - **CT.gov Last Update:** 2021-07-06 ## Brief Summary To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country * Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active * Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital * Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV * Subjects with type 2 diabetes mellitus and / or * Subjects with 30 mL/min/1.73m\^2 \/= 90 mmHg without signs and symptoms of hypotension at the screening visit Exclusion Criteria: * Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis * Acute coronary syndrome (ACS) in last 30 days prior to screening * Cardiogenic shock * Valvular heart disease requiring surgical intervention during the course of the study * Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit * Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic ``` ## Arms - **Finerenone(BAY94-8862)[2.5mg] + Placebo** (EXPERIMENTAL) — Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. - **Finerenone (BAY94-8862)[5mg] + Placebo** (EXPERIMENTAL) — Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. - **Finerenone (BAY94-8862)[7.5mg] + Placebo** (EXPERIMENTAL) — Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. - **Finerenone (BAY94-8862)[10mg] + Placebo** (EXPERIMENTAL) — Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. - **Finerenone (BAY94-8862)[15mg] + Placebo** (EXPERIMENTAL) — Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. - **Eplerenone [25 mg] + Placebo** (ACTIVE_COMPARATOR) — Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days. ## Interventions - **Finerenone (BAY94-8862)** (DRUG) - **Placebo** (DRUG) - **Inspra (eplerenone)** (DRUG) ## Primary Outcomes - **Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90** _(time frame: Baseline and Day 90)_ — N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure. ## Secondary Outcomes - **Number of Participants With Death Due to Any Cause** _(time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120))_ - **Number of Participants With Cardiovascular Hospitalization** _(time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120))_ - **Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)** _(time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120))_ - **Ratio of BNP at Specified Visits to BNP at Baseline** _(time frame: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120))_ - **Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline** _(time frame: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120))_ - **Change From Baseline in KCCQ Questionnaire Scores at Specified Visits** _(time frame: Baseline, Day 30 and Day 90)_ - **Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits** _(time frame: Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120))_ ## Locations (172) - Birmingham, Alabama, United States - La Jolla, California, United States - Los Angeles, California, United States - Jacksonville, Florida, United States - Macon, Georgia, United States - Baltimore, Maryland, United States - Detroit, Michigan, United States - Detroit, Michigan, United States - Newark, New Jersey, United States - Fairfield, Ohio, United States - Darlinghurst, New South Wales, Australia - Adelaide, South Australia, Australia - Concord, Australia - Prahran, Australia - Krems, Lower Austria, Austria - Graz, Styria, Austria - Graz, Styria, Austria - Innsbruck, Tyrol, Austria - Linz, Upper Austria, Austria - Salzburg, Austria - Vienna, Austria - Burgas, Bulgaria - Pazardzhik, Bulgaria - Rousse, Bulgaria - Sofia, Bulgaria - Sofia, Bulgaria - Sofia, Bulgaria - Varna, Bulgaria - Calgary, Alberta, Canada - Ottawa, Ontario, Canada - Toronto, Ontario, Canada - Montreal, Quebec, Canada - Montreal, Quebec, Canada - Montreal, Quebec, Canada - Saint-Jean-sur-Richelieu, Quebec, Canada - Sherbrooke, Quebec, Canada - Québec, Canada - Jindřichův Hradec, Czechia - Ostrava, Czechia - Prague, Czechia - Slaný, Czechia - Copenhagen Ø, Denmark - Esbjerg, Denmark - Glostrup Municipality, Denmark - Hellerup, Denmark - Herlev, Denmark - Hvidovre, Denmark - København NV, Denmark - Køge, Denmark - Svendborg, Denmark - Viborg, Denmark - Espoo, Finland - Helsinki, Finland - Rovaniemi, Finland - Turku, Finland - Bron, France - Nice, France - Paris, France - Paris, France - Rouen, France - Toulouse, France - Vandœuvre-lès-Nancy, France - Würzburg, Bavaria, Germany - Frankfurt am Main, Hesse, Germany - Limburg an der Lahn, Hesse, Germany - Göttingen, Lower Saxony, Germany - Hanover, Lower Saxony, Germany - Stade, Lower Saxony, Germany - Bad Oeynhausen, North Rhine-Westphalia, Germany - Mönchengladbach, North Rhine-Westphalia, Germany - Homburg, Saarland, Germany - Erfurt, Thuringia, Germany - Berlin, Germany - Athens, Greece - Athens, Greece - Chaïdári, Greece - Larissa, Greece - Nea Ionia / Athens, Greece - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Nagykanizsa, Hungary - Székesfehérvár, Hungary - Afula, Israel - Ashkelon, Israel - Hadera, Israel - Haifa, Israel - Jerusalem, Israel - Kfar Saba, Israel - Nahariya, Israel - Petah Tikva, Israel - Rehovot, Israel - Safed, Israel - Tel Aviv, Israel - Ẕerifin, Israel - Foggia, Apulia, Italy - Rome, Lazio, Italy - Bergamo, Lombardy, Italy - Milan, Lombardy, Italy - Monza Brianza, Lombardy, Italy - Arezzo, Tuscany, Italy - Pisa, Tuscany, Italy - Perugia, Umbria, Italy - Kaunas, Lithuania - Kaunas, Lithuania - Kaunas, Lithuania - Klaipėda, Lithuania - Klaipėda, Lithuania - Vilnius, Lithuania - Amsterdam, Netherlands - Delft, Netherlands - Groningen, Netherlands - Groningen, Netherlands - Hoogeveen, Netherlands - Nijmegen, Netherlands - Rotterdam, Netherlands - Veldhoven, Netherlands - Zutphen, Netherlands - Stavanger, Norway - Bialystok, Poland - Bydgoszcz, Poland - Gdansk, Poland - Katowice, Poland - Kielce, Poland - Krakow, Poland - Szczecin, Poland - Warsaw, Poland - Wroclaw, Poland - Almada, Portugal - Faro, Portugal - Lisbon, Portugal - Lisbon, Portugal - Lisbon, Portugal - Porto, Portugal - Petoria, Gauteng, South Africa - Isipingo Rail, KwaZulu-Natal, South Africa - Merebank, KwaZulu-Natal, South Africa - Tongaat, KwaZulu-Natal, South Africa - Cape Town, Western Cape, South Africa - Kuils River, Western Cape, South Africa - Pinelands, Western Cape, South Africa - Somerset West, Western Cape, South Africa - Worcester, Western Cape, South Africa - Wŏnju, Gang''weondo, South Korea - Seoul, South Korea - Seoul, South Korea - Seoul, South Korea - Olot, Girona, Spain - Majadahonda, Madrid, Spain - El Palmar, Murcia, Spain - Barcelona, Spain - Barcelona, Spain - Madrid, Spain - Valencia, Spain - Valencia, Spain - Falun, Sweden - Gothenburg, Sweden - Örebro, Sweden - Stockholm, Sweden - Stockholm, Sweden - Stockholm, Sweden - Umeå, Sweden - New Taipei City, Taiwan - Taipei, Taiwan - Taipei, Taiwan - Taipei, Taiwan - Taizung, Taiwan - Ankara, Turkey (Türkiye) - Ankara, Turkey (Türkiye) - Ankara, Turkey (Türkiye) - Antalya, Turkey (Türkiye) - Izmir, Turkey (Türkiye) ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.|la jolla|california|united states` — added _(2026-05-12)_ - `locations.|los angeles|california|united states` — added _(2026-05-12)_ - `locations.|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.|macon|georgia|united states` — added _(2026-05-12)_ - `locations.|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.|newark|new jersey|united states` — added _(2026-05-12)_ - `locations.|fairfield|ohio|united states` — added _(2026-05-12)_ - `locations.|darlinghurst|new south wales|australia` — added _(2026-05-12)_ - `locations.|adelaide|south australia|australia` — added _(2026-05-12)_ - `locations.|concord||australia` — added _(2026-05-12)_ - `locations.|prahran||australia` — added _(2026-05-12)_ - `locations.|krems|lower austria|austria` — added _(2026-05-12)_ - `locations.|graz|styria|austria` — added _(2026-05-12)_ - `locations.|innsbruck|tyrol|austria` — added _(2026-05-12)_ - `locations.|linz|upper austria|austria` — added _(2026-05-12)_ - `locations.|salzburg||austria` — added _(2026-05-12)_ - `locations.|vienna||austria` — added _(2026-05-12)_ - `locations.|burgas||bulgaria` — added _(2026-05-12)_ - `locations.|pazardzhik||bulgaria` — added _(2026-05-12)_ - `locations.|rousse||bulgaria` — added _(2026-05-12)_ - `locations.|sofia||bulgaria` — added _(2026-05-12)_ - `locations.|varna||bulgaria` — added _(2026-05-12)_ - `locations.|calgary|alberta|canada` — added _(2026-05-12)_ - `locations.|ottawa|ontario|canada` — added _(2026-05-12)_ - `locations.|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.|saint-jean-sur-richelieu|quebec|canada` — added _(2026-05-12)_ - `locations.|sherbrooke|quebec|canada` — added _(2026-05-12)_ - `locations.|québec||canada` — added _(2026-05-12)_ - `locations.|jindřichův hradec||czechia` — added _(2026-05-12)_ - `locations.|ostrava||czechia` — added _(2026-05-12)_ - `locations.|prague||czechia` — added _(2026-05-12)_ - `locations.|slaný||czechia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01807221.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01807221* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*