AzTrials
AzTrials

Heart FailurePhase 2ARTS-HFNCT01807221

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

A Phase 2 study testing Finerenone (BAY94-8862) and Inspra (eplerenone) in people with Heart Failure, run by Bayer at 172 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Finerenone (BAY94-8862) and Inspra (eplerenone)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,066 participants
Where
172 sitesin 25 countries
Study dates
17 Jun 2013to 9 Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

172 sites in 25 countries.

172 sites in 25 countries

Israel12 sites

  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Hadera, 3810101

  • Study site

    Haifa, 3436212

  • Study site

    Jerusalem, 9103102

  • Study site

    Kfar Saba, 4428164

  • Study site

    Nahariya, 2210001

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 7610001

  • Study site

    Safed, 1311001

  • Study site

    Tel Aviv, 64239

  • Study site

    Tsrifin, 7030000

Other trials in Israel

Germany11 sites

  • Study site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Study site

    Berlin, 13353

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Göttingen, Lower Saxony, 37099

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Limburg an der Lahn, Hesse, 65549

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Study site

    Stade, Lower Saxony, 21682

  • Study site

    Würzburg, Bavaria, 97078

Other trials in Germany

United States10 sites

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Birmingham, Alabama, 35294-2041

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fairfield, Ohio, 45014

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    La Jolla, California, 92037

  • Study site

    Los Angeles, California, 90033

  • Study site

    Macon, Georgia, 31201

  • Study site

    Newark, New Jersey, 07103

Other trials in United States

Denmark10 sites

  • Study site

    Copenhagen Ø, 2100

  • Study site

    Esbjerg, 6700

  • Study site

    Glostrup Municipality, 2600

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Hvidovre, 2650

  • Study site

    København NV, 2400

  • Study site

    Køge, 4600

  • Study site

    Svendborg, 5700

  • Study site

    Viborg, 8800

Other trials in Denmark

Canada9 sites

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Ottawa, Ontario, K1Y 4W7

  • Study site

    Québec, G1V 4G5

  • Study site

    Saint-Jean-sur-Richelieu, Quebec, J3A 1C3

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Netherlands9 sites

  • Study site

    Amsterdam, 1061 AE

  • Study site

    Delft, 2625 AD

  • Study site

    Groningen, 9700 RB

  • Study site

    Groningen, 9728 NT

  • Study site

    Hoogeveen, 7909 AA

  • Study site

    Nijmegen, 6525 GA

  • Study site

    Rotterdam, 3045 PM

  • Study site

    Veldhoven, 5504 DB

  • Study site

    Zutphen, 7207 AE

Other trials in Netherlands

Poland9 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-681

  • Study site

    Gdansk, 80-952

  • Study site

    Katowice, 40-635

  • Study site

    Kielce, 25-736

  • Study site

    Krakow, 31-121

  • Study site

    Szczecin, 70-965

  • Study site

    Warsaw, 04-628

  • Study site

    Wroclaw, 50-981

Other trials in Poland

South Africa9 sites

  • Study site

    Cape Town, Western Cape, 7500

  • Study site

    Isipingo Rail, KwaZulu-Natal, 4110

  • Study site

    Kuils River, Western Cape, 7580

  • Study site

    Merebank, KwaZulu-Natal, 4052

  • Study site

    Petoria, Gauteng

  • Study site

    Pinelands, Western Cape, 7405

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Tongaat, KwaZulu-Natal, 4400

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Italy8 sites

  • Study site

    Arezzo, Tuscany, 52040

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Foggia, Apulia, 71100

  • Study site

    Milan, Lombardy, 20149

  • Study site

    Monza Brianza, Lombardy, 20900

  • Study site

    Perugia, Umbria, 06129

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Rome, Lazio, 00163

Other trials in Italy

Spain8 sites

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08035

  • Study site

    El Palmar, Murcia, 30120

  • Study site

    Madrid, 28041

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Olot, Girona, 17800

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46026

Other trials in Spain

Austria7 sites

  • Study site

    Graz, Styria, 8020

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, Tyrol, 6020

  • Study site

    Krems, Lower Austria, 3500

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1100

Other trials in Austria

Bulgaria7 sites

  • Study site

    Burgas, 8018

  • Study site

    Pazardzhik, 4400

  • Study site

    Rousse, 7002

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1309

  • Study site

    Sofia, 1431

  • Study site

    Varna, 9010

Other trials in Bulgaria

France7 sites

  • Study site

    Bron, 69677

  • Study site

    Nice, 06200

  • Study site

    Paris, 75013

  • Study site

    Paris, 75475

  • Study site

    Rouen, 76031

  • Study site

    Toulouse, 31403

  • Study site

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Sweden7 sites

  • Study site

    Falun, 791 82

  • Study site

    Gothenburg, 416 85

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 141 86

  • Study site

    Stockholm, 182 88

  • Study site

    Umeå, 901 85

Other trials in Sweden

Lithuania6 sites

  • Study site

    Kaunas, LT-44320

  • Study site

    Kaunas, LT-47144

  • Study site

    Kaunas, LT-50161

  • Study site

    Klaipėda, 92288

  • Study site

    Klaipėda, LT-92288

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

Portugal6 sites

  • Study site

    Almada, 2801-951

  • Study site

    Faro, 8000-386

  • Study site

    Lisbon, 1449-005

  • Study site

    Lisbon, 1500-650

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, P-4200

Other trials in Portugal

Greece5 sites

  • Study site

    Athens, 11526

  • Study site

    Athens, 11527

  • Study site

    Chaïdári, 12462

  • Study site

    Larissa, 41100

  • Study site

    Nea Ionia / Athens, 14233

Other trials in Greece

Hungary5 sites

  • Study site

    Budapest, 1027

  • Study site

    Budapest, 1085

  • Study site

    Budapest, 1097

  • Study site

    Nagykanizsa, 8800

  • Study site

    Székesfehérvár, 8000

Other trials in Hungary

Taiwan5 sites

  • Study site

    New Taipei City, 220

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 11217

  • Study site

    Taipei

  • Study site

    Taizung, 402

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Study site

    Ankara, 06100

  • Study site

    Ankara, 06500

  • Study site

    Ankara

  • Study site

    Antalya, 07003

  • Study site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Australia4 sites

  • Study site

    Adelaide, South Australia, 5042

  • Study site

    Concord, 2139

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Prahran, 3004

Other trials in Australia

Czechia4 sites

  • Study site

    Jindřichův Hradec, 377 01

  • Study site

    Ostrava, 728 80

  • Study site

    Prague, 150 30

  • Study site

    Slaný, 274 01

Other trials in Czechia

Finland4 sites

  • Study site

    Espoo, 02740

  • Study site

    Helsinki, 00099

  • Study site

    Rovaniemi, 96101

  • Study site

    Turku, 20520

Other trials in Finland

South Korea4 sites

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 05505

  • Study site

    Wŏnju, Gang''weondo, 26426

Other trials in South Korea

Norway1 site

  • Study site

    Stavanger, 4011

Other trials in Norway

About this study

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

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.

Conditions
Heart Failure
Being tested
Finerenone (BAY94-8862), Placebo, Inspra (eplerenone)
Keywords
Heart Decompensation
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone (BAY94-8862)Drug

  • PlaceboDrug

  • Inspra (eplerenone)Drug

Study groups in NCT01807221
Study groupRoleWhat they receive
Finerenone(BAY94-8862)[2.5mg] + PlaceboExperimentalOral - 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.
Receives: Drug: Finerenone (BAY94-8862); Drug: Placebo
Finerenone (BAY94-8862)[5mg] + PlaceboExperimentalOral - 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.
Receives: Drug: Finerenone (BAY94-8862); Drug: Placebo
Finerenone (BAY94-8862)[7.5mg] + PlaceboExperimentalOral - 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.
Receives: Drug: Finerenone (BAY94-8862); Drug: Placebo
Finerenone (BAY94-8862)[10mg] + PlaceboExperimentalOral - 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.
Receives: Drug: Finerenone (BAY94-8862); Drug: Placebo
Finerenone (BAY94-8862)[15mg] + PlaceboExperimentalOral - 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.
Receives: Drug: Finerenone (BAY94-8862); Drug: Placebo
Eplerenone [25 mg] + PlaceboActive comparatorOral - 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.
Receives: Drug: Placebo; Drug: Inspra (eplerenone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to 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.

    Measured: Baseline and Day 90

Secondary outcomes (7)

  1. Number of Participants With Death Due to Any Cause

    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.

    Measured: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

  2. Number of Participants With Cardiovascular Hospitalization

    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.

    Measured: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

  3. Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)

    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.

    Measured: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

  4. Ratio of BNP at Specified Visits to BNP at Baseline

    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.

    Measured: 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)

  5. Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline

    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.

    Measured: 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)

  6. Change From Baseline in KCCQ Questionnaire Scores at Specified Visits

    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.

    Measured: Baseline, Day 30 and Day 90

  7. Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2013 (estimated)
  2. Study start17 Jun 2013
  3. Primary completion11 Nov 2014
  4. Study completion9 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,066 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01807221
Sponsor's protocol ID
14564
Other IDs
2012-002627-15
Acronym
ARTS-HF
Status last verified
Jul 2021
First submitted
7 Mar 2013
Last updated
6 Jul 2021
Data monitoring committee
Yes

Publications

  • Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.

    PubMed 27130705

  • Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

    PubMed 33107592

  • Pitt B, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218.

    PubMed 25678098

  • Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2026 Feb 1;37(2):312-325. doi: 10.1681/ASN.0000000823. Epub 2025 Sep 12.

    PubMed 40938666

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Finerenone (BAY94-8862) and Inspra (eplerenone) in people with Heart Failure, run by Bayer at 172 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in Israel, Germany, United States, Denmark, Canada and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01807221, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in