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Heart FailurePhase 2NCT01951625

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

A Phase 2 study testing Vericiguat (BAY1021189) (1.25 mg) and Vericiguat (BAY1021189) (5 mg) in people with Heart Failure, run by Bayer at 157 sites in 24 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

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF). 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?
Vericiguat (BAY1021189) (1.25 mg) and Vericiguat (BAY1021189) (5 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
456 participants
Where
157 sitesin 24 countries
Study dates
29 Nov 2013to 9 Jun 2015
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

  • Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
  • Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization

Who cannot join

  • Intravenous inotropes at any time after hospitalization

Trial locations and contacts

157 sites in 24 countries.

157 sites in 24 countries

Japan20 sites

  • Study site

    Fukui, 910-8526

  • Study site

    Himeji, Hyōgo, 670-0981

  • Study site

    Hiroshima, 734-8530

  • Study site

    Iizuka, Fukuoka, 820-8505

  • Study site

    Kanazawa, Ishikawa-ken, 920-8650

  • Study site

    Komatsushimachō, Tokushima, 773-8502

  • Study site

    Kumamoto, 862-8505

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Minato-ku, Tokyo, 106-0031

  • Study site

    Nagasaki, 850-8555

  • Study site

    Naha, Okinawa, 902-8511

  • Study site

    Sagamihara, Kanagawa, 252-5188

  • Study site

    Sendai, Miyagi, 981-3133

  • Study site

    Takatsuki, Osaka, 569-1096

  • Study site

    Tokushima, 770-8539

  • Study site

    Toyama, 930-8550

  • Study site

    Ureshino, Saga-ken, 843-0393

  • Study site

    Yao, Osaka, 581-0011

  • Study site

    Yokohama, Kanagawa, 236-0051

  • Study site

    Yokosuka, Kanagawa, 238-8567

Other trials in Japan

United States18 sites

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Buffalo, New York, 14215

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fairfield, Ohio, 45014

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Jackson, Mississippi, 39216-4505

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Macon, Georgia, 31201

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Minneapolis, Minnesota, 55422

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37232-8802

  • Study site

    New Orleans, Louisiana, 70112-1396

  • Study site

    Wilmington, Delaware, 19803

Other trials in United States

Germany10 sites

  • Study site

    Bad Homburg, Hesse, 61348

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66424

  • Study site

    München, Bavaria, 80331

  • Study site

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Italy10 sites

  • Study site

    Ancona, The Marches, 60126

  • Study site

    Arezzo, Tuscany, 52040

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Brescia, Lombardy, 25123

  • Study site

    Como, Lombardy, 22020

  • Study site

    Milan, Lombardy, 20017

  • Study site

    Milan, Lombardy, 20138

  • Study site

    Milan, Lombardy, 20149

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Verona, Veneto, 37045

Other trials in Italy

Israel9 sites

  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Hadera, 3810101

  • Study site

    Jerusalem, 9103102

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tiberias, 1528001

  • Study site

    Zrifin, 7030000

Other trials in Israel

Belgium8 sites

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Ghent, 9000

  • Study site

    Gilly, 6060

  • Study site

    Huy, 4500

  • Study site

    Mechelen, 2800

  • Study site

    Mol, 2400

  • Study site

    Roeselare, 8800

Other trials in Belgium

Czechia8 sites

  • Study site

    Hradec Králové, 500 05

  • Study site

    Kroměříž, 767 01

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Study site

    Prague, 10034

  • Study site

    Prague, 12808

  • Study site

    Prague, 140 21

  • Study site

    Prague, 169 02

  • Study site

    Slaný, 274 01

Other trials in Czechia

Poland7 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Krakow, 31-202

  • Study site

    Legnica, 59-220

  • Study site

    Lodz, 92-213

  • Study site

    Olsztyn, 10-010

  • Study site

    Poznan, 61-848

  • Study site

    Warsaw, 02-507

Other trials in Poland

Spain7 sites

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08023

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46026

Other trials in Spain

Canada6 sites

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Québec, G1V 4G5

  • Study site

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

  • Study site

    Sherbrooke, Quebec, J1G 2E8

  • Study site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

France6 sites

  • Study site

    Bron, 69677

  • Study site

    La Tronche, 38700

  • Study site

    Lille, 59037

  • Study site

    Paris, 75908

  • Study site

    Pessac, 33604

  • Study site

    Rouen, 76031

Other trials in France

Sweden6 sites

  • Study site

    Helsingborg, 251 87

  • Study site

    Karlstad, 651 85

  • Study site

    Linköping, 581 85

  • Study site

    Malmö, 205 02

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 118 83

Other trials in Sweden

Austria5 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Salzburg, 5020

  • Study site

    Sankt Pölten, Lower Austria, 3100

  • Study site

    Vienna, 1220

Other trials in Austria

Bulgaria5 sites

  • Study site

    Sofia, 1202

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1309

  • Study site

    Sofia, 1527

  • Study site

    Stara Zagora, 6000

Other trials in Bulgaria

Netherlands5 sites

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Deventer, 7416 SE

  • Study site

    Heerenveen, 8441 PW

  • Study site

    Leeuwarden, 8901 BR

  • Study site

    Veldhoven, 5504 DB

Other trials in Netherlands

Denmark4 sites

  • Study site

    Aalborg, 9000

  • Study site

    Aarhus N, 8200

  • Study site

    Hellerup, DK-2900

  • Study site

    Viborg, 8800

Other trials in Denmark

Singapore4 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 169609

  • Study site

    Singapore, 308433

  • Study site

    Singapore, 768828

Other trials in Singapore

Switzerland4 sites

  • Study site

    Bruderholz, 4101

  • Study site

    Liestal, Basel-Landschaft, 4410

  • Study site

    Lugano, 6900

  • Study site

    Zurich, 8091

Other trials in Switzerland

Taiwan4 sites

  • Study site

    Kaohsiung City, 813

  • Study site

    New Taipei City, 220

  • Study site

    Taipei, 10016

  • Study site

    Taipei, 11217

Other trials in Taiwan

Australia3 sites

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Prahran, Victoria, 3181

Other trials in Australia

Hungary3 sites

  • Study site

    Budapest, 1032

  • Study site

    Kistarcsa, H-2143

  • Study site

    Székesfehérvár, 8000

Other trials in Hungary

Greece2 sites

  • Study site

    Athens, 11527

  • Study site

    Nea Ionia, 14233

Other trials in Greece

United Kingdom2 sites

  • Study site

    Chesterfield, Derbyshire, S44 5DX

  • Study site

    Stevenage, Hertfordshire, SG1 4AB

Other trials in United Kingdom

South Korea1 site

  • Study site

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure With Reduced Ejection Fraction (HFrEF)

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

Conditions
Heart Failure
Being tested
Vericiguat (BAY1021189) (1.25 mg), Vericiguat (BAY1021189) (5 mg), Placebo
Keywords
Worsening Heart Failure, Heart Failure with Reduced Ejection Fraction
Medical subject headings
Heart Failure

What participants receive

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

  • Vericiguat (BAY1021189) (1.25 mg)Drug

    1.25 mg BAY1021189 tablets

  • Vericiguat (BAY1021189) (5 mg)Drug

    5 mg BAY1021189 tablets

  • PlaceboDrug

Study groups in NCT01951625
Study groupRoleWhat they receive
Vericiguat (BAY1021189) (10 mg)Experimental2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Vericiguat (BAY1021189) (5 mg)
Vericiguat (BAY1021189) (5 mg)Experimental2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Vericiguat (BAY1021189) (5 mg)
Vericiguat (BAY1021189) (2.5 mg)Experimental2.5 mg orally once daily for 12 weeks (with sham titrations)
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg)
Vericiguat (BAY1021189) (1.25 mg)Experimental1.25 mg orally once daily for 12 weeks (with sham titrations)
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg)
PlaceboPlacebo comparatorOrally once daily for 12 weeks (with sham titrations)
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12

    Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure.

    Measured: Baseline, Week 12

Timeline

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

  1. First posted26 Sep 2013 (estimated)
  2. Study start29 Nov 2013
  3. Primary completion14 May 2015
  4. Study completion9 Jun 2015

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
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951625
Sponsor's protocol ID
15371
Other IDs
2013-002287-11
Status last verified
Mar 2021
First submitted
24 Sep 2013
Last updated
25 Mar 2021
Data monitoring committee
Yes

Publications

  • Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Muller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

    PubMed 25056511

  • Gheorghiade M, Greene SJ, Butler J, Filippatos G, Lam CS, Maggioni AP, Ponikowski P, Shah SJ, Solomon SD, Kraigher-Krainer E, Samano ET, Muller K, Roessig L, Pieske B; SOCRATES-REDUCED Investigators and Coordinators. Effect of Vericiguat, a Soluble Guanylate Cyclase Stimulator, on Natriuretic Peptide Levels in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction: The SOCRATES-REDUCED Randomized Trial. JAMA. 2015 Dec 1;314(21):2251-62. doi: 10.1001/jama.2015.15734.

    PubMed 26547357

  • Ruehs H, Klein D, Frei M, Grevel J, Austin R, Becker C, Roessig L, Pieske B, Garmann D, Meyer M. Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. Clin Pharmacokinet. 2021 Nov;60(11):1407-1421. doi: 10.1007/s40262-021-01024-y. Epub 2021 Jun 4.

    PubMed 34086190

  • Kramer F, Voss S, Roessig L, Igl BW, Butler J, Lam CSP, Maggioni AP, Shah SJ, Pieske B. Evaluation of high-sensitivity C-reactive protein and uric acid in vericiguat-treated patients with heart failure with reduced ejection fraction. Eur J Heart Fail. 2020 Sep;22(9):1675-1683. doi: 10.1002/ejhf.1787. Epub 2020 Mar 25.

    PubMed 32216011

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vericiguat (BAY1021189) (1.25 mg) and Vericiguat (BAY1021189) (5 mg) in people with Heart Failure, run by Bayer at 157 sites in 24 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 2 inclusion and 1 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in Japan, United States, Germany, Italy, Israel and 19 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. Some participants in this study may receive a placebo. 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 25 Mar 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?

Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12 (time frame: Baseline, Week 12). 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 NCT01951625, 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 25 Mar 2021.

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