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 (ARTS-HF)

July 2, 2021 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1066

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia, 2139
      • Prahran, Australia, 3004
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
    • South Australia
      • Adelaide, South Australia, Australia, 5042
  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1100
    • Niederösterreich
      • Krems an der Donau, Niederösterreich, Austria, 3500
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
    • Steiermark
      • Graz, Steiermark, Austria, 8036
      • Graz, Steiermark, Austria, 8020
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Bulgaria
      • Burgas, Bulgaria, 8018
      • Pazardzhik, Bulgaria, 4400
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1309
      • Varna, Bulgaria, 9010
  • Canada
      • Quebec, Canada, G1V 4G5
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H2W 1T8
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
      • Sherbrooke, Quebec, Canada, J1H 5N4
  • Czechia
      • Jindrichuv Hradec, Czechia, 377 01
      • Ostrava, Czechia, 728 80
      • Praha 5, Czechia, 150 30
      • Slany, Czechia, 274 01
  • Denmark
      • Copenhagen Ø, Denmark, 2100
      • Esbjerg, Denmark, 6700
      • Glostrup, Denmark, 2600
      • Hellerup, Denmark, 2900
      • Herlev, Denmark, 2730
      • Hvidovre, Denmark, 2650
      • København NV, Denmark, 2400
      • Køge, Denmark, 4600
      • Svendborg, Denmark, 5700
      • Viborg, Denmark, 8800
  • Finland
      • Espoo, Finland, 02740
      • Helsinki, Finland, 00099
      • Rovaniemi, Finland, 96101
      • Turku, Finland, 20520
  • France
      • Bron, France, 69677
      • Nice, France, 06200
      • PARIS cedex 10, France, 75475
      • Paris cedex 13, France, 75013
      • Rouen, France, 76031
      • Toulouse, France, 31403
      • Vandoeuvre les Nancy, France, 54500
  • Germany
      • Berlin, Germany, 13353
    • Bayern
      • Würzburg, Bayern, Germany, 97078
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
      • Limburg, Hessen, Germany, 65549
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37099
      • Hannover, Niedersachsen, Germany, 30625
      • Stade, Niedersachsen, Germany, 21682
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
  • Greece
      • Athens, Greece, 11527
      • Athens, Greece, 11526
      • Chaidari, Greece, 12462
      • Larissa, Greece, 41100
      • Nea Ionia / Athens, Greece, 14233
  • Hungary
      • Budapest, Hungary, 1085
      • Budapest, Hungary, 1097
      • Budapest, Hungary, 1027
      • Nagykanizsa, Hungary, 8800
      • Szekesfehervar, Hungary, 8000
  • Israel
      • Afula, Israel, 1834111
      • Ashkelon, Israel, 7830604
      • Hadera, Israel, 3810101
      • Haifa, Israel, 3436212
      • Jerusalem, Israel, 9103102
      • Kfar Saba, Israel, 4428164
      • Nahariya, Israel, 2210001
      • Petach Tikva, Israel, 4941492
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 64239
      • Zefat, Israel, 1311001
      • Zerifin, Israel, 7030000
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00163
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
      • Milano, Lombardia, Italy, 20149
      • Monza Brianza, Lombardia, Italy, 20900
    • Puglia
      • Foggia, Puglia, Italy, 71100
    • Toscana
      • Arezzo, Toscana, Italy, 52040
      • Pisa, Toscana, Italy, 56124
    • Umbria
      • Perugia, Umbria, Italy, 06129
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 03722
    • Gang''weondo
      • Wonju, Gang''weondo, Korea, Republic of, 26426
  • Lithuania
      • Kaunas, Lithuania, LT-50161
      • Kaunas, Lithuania, LT-47144
      • Kaunas, Lithuania, LT-44320
      • Klaipeda, Lithuania, 92288
      • Klaipeda, Lithuania, LT-92288
      • Vilnius, Lithuania, LT-08661
  • Netherlands
      • Amsterdam, Netherlands, 1061 AE
      • Delft, Netherlands, 2625 AD
      • Groningen, Netherlands, 9700 RB
      • Groningen, Netherlands, 9728 NT
      • Hoogeveen, Netherlands, 7909 AA
      • Nijmegen, Netherlands, 6525 GA
      • Rotterdam, Netherlands, 3045 PM
      • Veldhoven, Netherlands, 5504 DB
      • Zutphen, Netherlands, 7207 AE
  • Norway
      • Stavanger, Norway, 4011
  • Poland
      • Bialystok, Poland, 15-276
      • Bydgoszcz, Poland, 85-681
      • Gdansk, Poland, 80-952
      • Katowice, Poland, 40-635
      • Kielce, Poland, 25-736
      • Krakow, Poland, 31-121
      • Szczecin, Poland, 70-965
      • Warszawa, Poland, 04-628
      • Wroclaw, Poland, 50-981
  • Portugal
      • Almada, Portugal, 2801-951
      • Faro, Portugal, 8000-386
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1449-005
      • Lisboa, Portugal, 1500-650
      • Porto, Portugal, P-4200
  • South Africa
    • Gauteng
      • Petoria, Gauteng, South Africa
    • Kwazulu-Natal
      • Isipingo Rail, Kwazulu-Natal, South Africa, 4110
      • Merebank, Kwazulu-Natal, South Africa, 4052
      • Tongaat, Kwazulu-Natal, South Africa, 4400
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
      • Kuils River, Western Cape, South Africa, 7580
      • Pinelands, Western Cape, South Africa, 7405
      • Somerset West, Western Cape, South Africa, 7130
      • Worcester, Western Cape, South Africa, 6850
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
    • Girona
      • Olot, Girona, Spain, 17800
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
    • Murcia
      • El Palmar, Murcia, Spain, 30120
  • Sweden
      • Falun, Sweden, 791 82
      • Göteborg, Sweden, 416 85
      • Stockholm, Sweden, 141 86
      • Stockholm, Sweden, 182 88
      • Stockholm, Sweden, 118 83
      • Umeå, Sweden, 901 85
      • Örebro, Sweden, 701 85
  • Taiwan
      • New Taipei City, Taiwan, 220
      • Taipei, Taiwan
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 10002
      • Taizung, Taiwan, 402
  • Turkey
      • Ankara, Turkey
      • Ankara, Turkey, 06100
      • Ankara, Turkey, 06500
      • Antalya, Turkey, 07003
      • Izmir, Turkey, 35100
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2041
    • California
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90033
    • Florida
      • Jacksonville, Florida, United States, 32209
    • Georgia
      • Macon, Georgia, United States, 31201
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • Ohio
      • Fairfield, Ohio, United States, 45014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
  • Left ventricular ejection fraction (LVEF) </= 40%
  • Blood potassium </= 5.0 mmol/L at screening
  • Systolic blood pressure >/= 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Finerenone(BAY94-8862)[2.5mg] + Placebo
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.
Drug: Placebo
Drug: Finerenone (BAY94-8862)
EXPERIMENTAL: Finerenone (BAY94-8862)[5mg] + Placebo
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.
Drug: Placebo
Drug: Finerenone (BAY94-8862)
EXPERIMENTAL: Finerenone (BAY94-8862)[7.5mg] + Placebo
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.
Drug: Placebo
Drug: Finerenone (BAY94-8862)
EXPERIMENTAL: Finerenone (BAY94-8862)[10mg] + Placebo
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.
Drug: Placebo
Drug: Finerenone (BAY94-8862)
EXPERIMENTAL: Finerenone (BAY94-8862)[15mg] + Placebo
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.
Drug: Placebo
Drug: Finerenone (BAY94-8862)
ACTIVE_COMPARATOR: Eplerenone [25 mg] + Placebo
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.
Drug: Placebo
Drug: Inspra (eplerenone)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.
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)
Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.
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)
Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.
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)
B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
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)
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
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
The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.
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)
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Serum Potassium at Specified Visits
Time Frame: Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Systolic Blood Pressure at Specified Visits
Time Frame: Baseline,Day 7,14,30,60,90,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)
Baseline,Day 7,14,30,60,90,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 Diastolic Blood Pressure at Specified Visits
Time Frame: Baseline,Day 7,14,30,60,90,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)
Baseline,Day 7,14,30,60,90,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 Heart Rate at Specified Visits
Time Frame: Baseline,Day 7,14,30,60,90,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)
Baseline,Day 7,14,30,60,90,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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14564
  • 2012-002627-15 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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