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)
NCT ID: NCT01951625
Last Updated: 2021-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
456 participants
INTERVENTIONAL
2013-11-29
2015-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vericiguat (BAY1021189) (10 mg)
2.5 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
Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Vericiguat (BAY1021189) (5 mg)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Vericiguat (BAY1021189) (2.5 mg)
2.5 mg orally once daily for 12 weeks (with sham titrations)
Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Vericiguat (BAY1021189) (1.25 mg)
1.25 mg orally once daily for 12 weeks (with sham titrations)
Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Placebo
Orally once daily for 12 weeks (with sham titrations)
Placebo
Interventions
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Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Placebo
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction (LVEF) \<45% by echocardiography at randomization
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Fountain Valley, California, United States
Wilmington, Delaware, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Naples, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Buffalo, New York, United States
Columbus, Ohio, United States
Fairfield, Ohio, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Milwaukee, Wisconsin, United States
Darlinghurst, New South Wales, Australia
Hobart, Tasmania, Australia
Prahran, Victoria, Australia
Sankt Pölten, Lower Austria, Austria
Graz, Styria, Austria
Linz, Upper Austria, Austria
Salzburg, , Austria
Vienna, , Austria
Bruges, , Belgium
Bruxelles - Brussel, , Belgium
Ghent, , Belgium
Gilly, , Belgium
Huy, , Belgium
Mechelen, , Belgium
Mol, , Belgium
Roeselare, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jean-sur-Richelieu, Quebec, Canada
Sherbrooke, Quebec, Canada
Québec, , Canada
Hradec Králové, , Czechia
Kroměříž, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Slaný, , Czechia
Aalborg, , Denmark
Aarhus N, , Denmark
Hellerup, , Denmark
Viborg, , Denmark
Bron, , France
La Tronche, , France
Lille, , France
Paris, , France
Pessac, , France
Rouen, , France
München, Bavaria, Germany
Bad Homburg, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Hanover, Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Cologne, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Homburg, Saarland, Germany
Erfurt, Thuringia, Germany
Hamburg, , Germany
Athens, , Greece
Nea Ionia, , Greece
Budapest, , Hungary
Kistarcsa, , Hungary
Székesfehérvár, , Hungary
Afula, , Israel
Ashkelon, , Israel
Hadera, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tiberias, , Israel
Zrifin, , Israel
Bergamo, Lombardy, Italy
Brescia, Lombardy, Italy
Como, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Ancona, The Marches, Italy
Arezzo, Tuscany, Italy
Verona, Veneto, Italy
Iizuka, Fukuoka, Japan
Himeji, Hyōgo, Japan
Kanazawa, Ishikawa-ken, Japan
Sagamihara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokosuka, Kanagawa, Japan
Sendai, Miyagi, Japan
Naha, Okinawa, Japan
Takatsuki, Osaka, Japan
Yao, Osaka, Japan
Ureshino, Saga-ken, Japan
Komatsushimachō, Tokushima, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Fukui, , Japan
Hiroshima, , Japan
Kumamoto, , Japan
Nagasaki, , Japan
Tokushima, , Japan
Toyama, , Japan
Amsterdam, , Netherlands
Deventer, , Netherlands
Heerenveen, , Netherlands
Leeuwarden, , Netherlands
Veldhoven, , Netherlands
Bialystok, , Poland
Krakow, , Poland
Legnica, , Poland
Lodz, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Seoul, , South Korea
L'Hospitalet de Llobregat, Barcelona, Spain
Santander, Cantabria, Spain
Majadahonda, Madrid, Spain
Barcelona, , Spain
Barcelona, , Spain
Valencia, , Spain
Valencia, , Spain
Helsingborg, , Sweden
Karlstad, , Sweden
Linköping, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Liestal, Basel-Landschaft, Switzerland
Bruderholz, , Switzerland
Lugano, , Switzerland
Zurich, , Switzerland
Kaohsiung City, , Taiwan
New Taipei City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Chesterfield, Derbyshire, United Kingdom
Stevenage, Hertfordshire, United Kingdom
Countries
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References
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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.
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.
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.
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.
Related Links
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Other Identifiers
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2013-002287-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15371
Identifier Type: -
Identifier Source: org_study_id
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