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)

NCT01951638 | Completed Phase 2 Results DMC

• 2 other identifiers: 158292013-002288-25
• Study Type: interventional
• Target: 477
• Locations: 24 countries
• Sites: 151

Brief 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 diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

Conditions

Heart Failure

Keywords

Worsening Heart Failure; Heart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

  NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).

  Baseline, Week 12 (end of treatment [EOT])

• Change From Baseline to Week 12 in Left Atrial Volume (LAV)

  Left atrial volume was measured by echocardiography.

  Baseline, Week 12 (EOT)

Other Outcomes (3)

• Change From Baseline to Week 12 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

  Baseline, Week 12 (EOT)

• Change From Baseline to Week 12 in Heart Rate

  Baseline, Week 12 (EOT)

• Number of Subjects With Clinical Events (Heart Failure Hospitalization and Cardio-vascular [CV] Mortality)

  Baseline up to Week 16 including 12 week treatment period and 4 week follow-up period

Study Arms (5)

Vericiguat (BAY1021189)(10 mg)

EXPERIMENTAL

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

Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Vericiguat (BAY1021189) (5 mg)

Vericiguat (BAY1021189) (5 mg)

EXPERIMENTAL

2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)

Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Vericiguat (BAY1021189) (5 mg)

Vericiguat (BAY1021189) (2.5 mg)

EXPERIMENTAL

2.5 mg orally once daily for 12 weeks (with sham titrations)

Drug: Vericiguat (BAY1021189) (1.25 mg)

Vericiguat (BAY1021189) (1.25 mg)

EXPERIMENTAL

1.25 mg orally once daily for 12 weeks (with sham titrations)

Drug: Vericiguat (BAY1021189) (1.25 mg)

Placebo

PLACEBO COMPARATOR

Orally once daily for 12 weeks (with sham titrations)

Drug: Placebo

Interventions

Vericiguat (BAY1021189) (1.25 mg) DRUG

1.25 mg BAY1021189 tablets

Vericiguat (BAY1021189) (1.25 mg); Vericiguat (BAY1021189) (2.5 mg); Vericiguat (BAY1021189) (5 mg); Vericiguat (BAY1021189)(10 mg)

Vericiguat (BAY1021189) (5 mg) DRUG

5 mg BAY1021189 tablets

Vericiguat (BAY1021189) (5 mg); Vericiguat (BAY1021189)(10 mg)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intravenous inotropes at any time after hospitalization

Sponsors & Collaborators

• Bayer: lead

Study Sites (158)

Unknown Facility

Fountain Valley, California, 92708, United States

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Fort Lauderdale, Florida, 33308, United States

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Naples, Florida, 34102, United States

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Macon, Georgia, 31201, United States

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Chicago, Illinois, 60611-2908, United States

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Iowa City, Iowa, 52242, United States

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New Orleans, Louisiana, 70112-1396, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55422, United States

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Jackson, Mississippi, 39216-4505, United States

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Newark, New Jersey, 07103, United States

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Buffalo, New York, 14215, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Charleston, South Carolina, 29425, United States

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Germantown, Tennessee, 38138, United States

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Nashville, Tennessee, 37232-8802, United States

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Milwaukee, Wisconsin, 53215, United States

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Darlinghurst, New South Wales, 2010, Australia

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Brisbane, Queensland, 4029, Australia

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Brisbane, Queensland, 4064, Australia

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Redcliffe, Queensland, 4020, Australia

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Hobart, Tasmania, 7000, Australia

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Sankt Pölten, Lower Austria, 3100, Austria

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Graz, Styria, 8036, Austria

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Linz, Upper Austria, 4010, Austria

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Linz, Upper Austria, 4020, Austria

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Vienna, 1220, Austria

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Bruges, 8000, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Ghent, 9000, Belgium

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Gilly, 6060, Belgium

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Huy, 4500, Belgium

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Mechelen, 2800, Belgium

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Mol, 2400, Belgium

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Roeselare, 8800, Belgium

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Burgas, 8018, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1527, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Toronto, Ontario, M5B 1W8, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H2W 1T8, Canada

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

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Sherbrooke, Quebec, J1G 2E8, Canada

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Québec, G1V 4G5, Canada

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Kroměříž, 767 01, Czechia

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Prague, 10034, Czechia

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Prague, 12808, Czechia

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Prague, 140 21, Czechia

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Prague, 169 02, Czechia

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Aalborg, 9000, Denmark

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Holbæk, 4300, Denmark

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Randers, 8930, Denmark

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Bron, 69677, France

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Pessac, 33604, France

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Rouen, 76031, France

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Toulouse, 31403, France

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Bad Krozingen, Baden-Wurttemberg, 79189, Germany

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München, Bavaria, 80331, Germany

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Bad Homburg, Hesse, 61348, Germany

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Hanover, Lower Saxony, 30625, Germany

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Greifswald, Mecklenburg-Vorpommern, 17475, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Homburg, Saarland, 66421, Germany

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Erfurt, Thuringia, 99089, Germany

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Hamburg, 20246, Germany

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Athens, 11527, Greece

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Chaïdári, 12462, Greece

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Nea Ionia / Athens, 142 33, Greece

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Budapest, 1097, Hungary

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Kistarcsa, H-2143, Hungary

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Székesfehérvár, 8000, Hungary

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Afula, 1834111, Israel

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Ashkelon, 7830604, Israel

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Hadera, 3810101, Israel

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Haifa, 3109601, Israel

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Jerusalem, 9103102, Israel

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Petah Tikva, 4941492, Israel

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Rehovot, 7610001, Israel

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Tel Aviv, 6423906, Israel

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Tiberias, 1528001, Israel

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Zrifin, 7030000, Israel

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Bergamo, Lombardy, 24127, Italy

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Brescia, Lombardy, 25123, Italy

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Milan, Lombardy, 20017, Italy

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Milan, Lombardy, 20149, Italy

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Pavia, Lombardy, 27100, Italy

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Ancona, The Marches, 60126, Italy

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Arezzo, Tuscany, 52040, Italy

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Iizuka, Fukuoka, 820-8505, Japan

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Himeji, Hyōgo, 670-0981, Japan

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Higashiibaraki, Ibaraki, 311-3193, Japan

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Kanazawa, Ishikawa-ken, 920-8650, Japan

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Takamatsu, Kagawa-ken, 760-0018, Japan

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Sagamihara, Kanagawa, 252-5188, Japan

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Yokohama, Kanagawa, 236-0051, Japan

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Yokosuka, Kanagawa, 238-8567, Japan

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Uji, Kyoto, 611-0041, Japan

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Naha, Okinawa, 902-8511, Japan

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Sakai, Osaka, 599-8247, Japan

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Takatsuki, Osaka, 569-1096, Japan

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Komatsushimachō, Tokushima, 773-8502, Japan

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Meguro-ku, Tokyo, 152-8902, Japan

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Minato-ku, Tokyo, 106-0031, Japan

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Fukui, 910-8526, Japan

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Hiroshima, 734-8530, Japan

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Kumamoto, 862-8505, Japan

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Nagasaki, 850-8555, Japan

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Osaka, 558-8558, Japan

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Tokushima, 770-8539, Japan

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Toyama, 930-8550, Japan

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Amsterdam, 1105 AZ, Netherlands

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Heerenveen, 8441 PW, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Sneek, 8601 ZR, Netherlands

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Bialystok, 15-276, Poland

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Krakow, 31-121, Poland

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Krakow, 31-202, Poland

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Lodz, 92-213, Poland

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Lodz, 93-513, Poland

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Olsztyn, 10-010, Poland

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Poznan, 61-848, Poland

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Szczecin, 70-965, Poland

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Almada, 2801-951, Portugal

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Lisbon, 1449-005, Portugal

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Lisbon, 1500-650, Portugal

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Lisbon, 1649-035, Portugal

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Singapore, 119228, Singapore

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Singapore, 169609, Singapore

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Singapore, 308433, Singapore

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Singapore, 768828, Singapore

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Seoul, 138-736, South Korea

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Santander, Cantabria, 39008, Spain

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Majadahonda, Madrid, 28222, Spain

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El Palmar, Murcia, 30120, Spain

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Barcelona, 08003, Spain

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Barcelona, 08023, Spain

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Valencia, 46010, Spain

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Valencia, 46026, Spain

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Helsingborg, 251 87, Sweden

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Karlstad, 652 30, Sweden

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Linköping, 581 85, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 118 83, Sweden

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Lugano, Canton Ticino, 6900, Switzerland

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Geneva, 1205, Switzerland

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Kaohsiung City, 813, Taiwan

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New Taipei City, 220, Taiwan

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Taipei, 10016, Taiwan

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Taipei, 11217, Taiwan

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Taoyuan District, 333423, Taiwan

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Chesterfield, Derbyshire, S44 5DX, United Kingdom

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Stevenage, Hertfordshire, SG1 4AB, United Kingdom

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Related Publications (1)

• 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.

  PMID: 25056511 BACKGROUND

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Conditions

Heart Failure

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

End points, "Health-related quality of life, Composite Congestion Score, NYHA function class, echo parameters other than LAV, biomarker and background HF therapies" were exploratory. "Incidence of atrial fibrillation" is reported in AE section.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 26, 2013
• Study Start: November 6, 2013
• Primary Completion: August 18, 2015
• Study Completion: September 16, 2015
• Last Updated: March 16, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-02

Locations

DK (3); DE (10); BE (8); HU (3); AU (5); IL (10); US (17); IT (7); NL (4); BU (6); PT (4); CA (6); PL (8); SG (4); SE (5); CH (2); GB (2); JP (22); FR (4); TW (5); ES (7); GR (3); KR (1); CZ (5)