Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)
NCT ID: NCT01951638
Last Updated: 2021-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
477 participants
INTERVENTIONAL
2013-11-06
2015-09-16
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
Fort Lauderdale, Florida, United States
Naples, Florida, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Newark, New Jersey, United States
Buffalo, New York, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Milwaukee, Wisconsin, United States
Darlinghurst, New South Wales, Australia
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Redcliffe, Queensland, Australia
Hobart, Tasmania, Australia
Sankt Pölten, Lower Austria, Austria
Graz, Styria, Austria
Linz, Upper Austria, Austria
Linz, Upper Austria, Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Bruges, , Belgium
Bruxelles - Brussel, , Belgium
Ghent, , Belgium
Gilly, , Belgium
Huy, , Belgium
Mechelen, , Belgium
Mol, , Belgium
Roeselare, , Belgium
Burgas, , Bulgaria
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
Kroměříž, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Holbæk, , Denmark
Randers, , Denmark
Bron, , France
Pessac, , France
Rouen, , France
Toulouse, , France
Bad Krozingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Bad Homburg, 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
Chaïdári, , Greece
Nea Ionia / Athens, , Greece
Budapest, , Hungary
Kistarcsa, , Hungary
Székesfehérvár, , Hungary
Afula, , Israel
Ashkelon, , Israel
Hadera, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tiberias, , Israel
Zrifin, , Israel
Bergamo, Lombardy, Italy
Brescia, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Ancona, The Marches, Italy
Arezzo, Tuscany, Italy
Iizuka, Fukuoka, Japan
Himeji, Hyōgo, Japan
Higashiibaraki, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Sagamihara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokosuka, Kanagawa, Japan
Uji, Kyoto, Japan
Naha, Okinawa, Japan
Sakai, Osaka, Japan
Takatsuki, Osaka, Japan
Komatsushimachō, Tokushima, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Fukui, , Japan
Hiroshima, , Japan
Kumamoto, , Japan
Nagasaki, , Japan
Osaka, , Japan
Tokushima, , Japan
Toyama, , Japan
Amsterdam, , Netherlands
Heerenveen, , Netherlands
Leeuwarden, , Netherlands
Sneek, , Netherlands
Bialystok, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Olsztyn, , Poland
Poznan, , Poland
Szczecin, , Poland
Almada, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Seoul, , South Korea
Santander, Cantabria, Spain
Majadahonda, Madrid, Spain
El Palmar, Murcia, Spain
Barcelona, , Spain
Barcelona, , Spain
Valencia, , Spain
Valencia, , Spain
Helsingborg, , Sweden
Karlstad, , Sweden
Linköping, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Lugano, Canton Ticino, Switzerland
Geneva, , Switzerland
Kaohsiung City, , Taiwan
New Taipei City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , 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.
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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2013-002288-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15829
Identifier Type: -
Identifier Source: org_study_id
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