check_circleStudy Completed
Heart Failure
Bayer Identifier:
15829
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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)
Trial purpose
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)
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
477Trial Dates
November 2013 - September 2015Phase
Phase 2Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pittsburgh, 15212, United States | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Withdrawn | Warszawa, 04-628, Poland | |
Completed | Valencia, 46026, Spain | |
Completed | Majadahonda, 28222, Spain | |
Withdrawn | L'Hospitalet de Llobregat, 08907, Spain | |
Completed | Barcelona, 08023, Spain | |
Completed | Barcelona, 08003, Spain | |
Completed | Santander, 39008, Spain | |
Withdrawn | Barcelona, 08006, Spain | |
Completed | 169609, Singapore | |
Completed | Singapore, 308433, Singapore | |
Completed | Singapore, 768828, Singapore | |
Completed | Singapore, 119228, Singapore | |
Completed | Homburg, 66421, Germany | |
Completed | Erfurt, 99089, Germany | |
Completed | Köln, 50937, Germany | |
Completed | Greifswald, 17475, Germany | |
Completed | Hamburg, 20246, Germany | |
Completed | München, 80331, Germany | |
Completed | Münster, 48149, Germany | |
Completed | Graz, 8036, Austria | |
Completed | Wien, 1220, Austria | |
Completed | Salzburg, 5020, Austria | |
Completed | St. Pölten, 3100, Austria | |
Completed | Wien, 1090, Austria | |
Completed | Buffalo, 14215, United States | |
Withdrawn | Indianapolis, 46260, United States | |
Withdrawn | Atlanta, 30322, United States | |
Withdrawn | Los Angeles, 90048, United States | |
Completed | Fountain Valley, 92708, United States | |
Withdrawn | La Jolla, 92037, United States | |
Completed | Milwaukee, 53215, United States | |
Completed | Sherbrooke, J1G 2E8, Canada | |
Completed | Toronto, M5B 1W8, Canada | |
Completed | Quebec, G1V 4G5, Canada | |
Withdrawn | Scarborough, M1P 2V5, Canada | |
Withdrawn | Brampton, L6Z 4N5, Canada | |
Completed | Sneek, 8601 ZR, Netherlands | |
Withdrawn | DEVENTER, 7416 SE, Netherlands | |
Completed | LEEUWARDEN, 8934 AD, Netherlands | |
Withdrawn | Eger, 3300, Hungary | |
Completed | Szekesfehervar, 8000, Hungary | |
Completed | Budapest, 1097, Hungary | |
Withdrawn | Bruderholz, 4101, Switzerland | |
Withdrawn | Basel, 4031, Switzerland | |
Completed | Genève, 1205, Switzerland | |
Completed | Lugano, 6900, Switzerland | |
Completed | Praha 10, 10034, Czechia | |
Completed | Praha 6, 169 02, Czechia | |
Completed | Praha 2, 12808, Czechia | |
Withdrawn | Ostrava, 708 52, Czechia | |
Withdrawn | Hradec kralove, 500 05, Czechia | |
Completed | Brescia, 25123, Italy | |
Withdrawn | Milano, 20138, Italy | |
Withdrawn | Verona, 37045, Italy | |
Completed | Pavia, 27100, Italy | |
Completed | Milano, 20017, Italy | |
Completed | MECHELEN, 2800, Belgium | |
Completed | MOL, 2400, Belgium | |
Withdrawn | EDEGEM, 2650, Belgium | |
Completed | ROESELARE, 8800, Belgium | |
Completed | GILLY, 6060, Belgium | |
Completed | HEERENVEEN, 8441 PW, Netherlands | |
Withdrawn | WEERT, 6001 BE, Netherlands | |
Completed | Ashkelon, 7830604, Israel | |
Completed | Petah Tikva, 4941492, Israel | |
Completed | Rehovot, 7610001, Israel | |
Completed | Hadera, 3810101, Israel | |
Completed | Tel Aviv, 6423906, Israel | |
Completed | Afula, 1834111, Israel | |
Withdrawn | Ramat Gan, 5262000, Israel | |
Withdrawn | Budapest, 1115, Hungary | |
Withdrawn | Jaszbereny, 5100, Hungary | |
Withdrawn | Kaposvar, 7400, Hungary | |
Withdrawn | Budapest, 1032, Hungary | |
Withdrawn | Burlington, 05401-1420, United States | |
Withdrawn | Columbus, 43210, United States | |
Withdrawn | Detroit, 48201, United States | |
Completed | Detroit, 48202, United States | |
Withdrawn | Wroclaw, 50-981, Poland | |
Completed | Krakow, 31-202, Poland | |
Completed | Lodz, 92-213, Poland | |
Completed | Poznan, 61-848, Poland | |
Completed | Lodz, 93-513, Poland | |
Withdrawn | Legnica, 59-220, Poland | |
Withdrawn | Katowice, 40-635, Poland | |
Completed | Bialystok, 15-276, Poland | |
Withdrawn | Warszawa, 02-507, Poland | |
Completed | Olsztyn, 10-010, Poland | |
Withdrawn | Como, 22020, Italy | |
Completed | Ancona, 60126, Italy | |
Withdrawn | Milano, 20162, Italy | |
Withdrawn | HASSELT, 3500, Belgium | |
Completed | BRUGGE, 8000, Belgium | |
Withdrawn | Malmö, 205 02, Sweden | |
Completed | Stockholm, 118 83, Sweden | |
Completed | Helsingborg, 251 87, Sweden | |
Completed | Linköping, 581 85, Sweden | |
Withdrawn | Viborg, 8800, Denmark | |
Withdrawn | Hellerup, 2900, Denmark | |
Withdrawn | Vejle, 7100, Denmark | |
Completed | Aalborg, 9000, Denmark | |
Completed | Kistarcsa, H-2143, Hungary | |
Withdrawn | Budapest, 1085, Hungary | |
Withdrawn | Beijing, 100037, China | |
Withdrawn | Shanghai, 200032, China | |
Withdrawn | Sendai, 981-3133, Japan | |
Completed | Meguro-ku, 152-8902, Japan | |
Completed | Yokohama, 236-0051, Japan | |
Completed | Sagamihara, 252-5188, Japan | |
Withdrawn | Seto, 489-8642, Japan | |
Completed | Kanazawa, 920-8650, Japan | |
Completed | Fukui, 910-8526, Japan | |
Completed | Takatsuki, 569-1096, Japan | |
Completed | Himeji, 670-0981, Japan | |
Completed | Komatsushima, 773-8502, Japan | |
Completed | Tokushima, 770-8539, Japan | |
Completed | Hiroshima, 734-8530, Japan | |
Completed | Kumamoto, 862-8505, Japan | |
Completed | Nagasaki, 850-8555, Japan | |
Completed | Karlstad, 652 30, Sweden | |
Withdrawn | Alicante, 03010, Spain | |
Completed | Nashville, 37232-8802, United States | |
Withdrawn | Cambridge, N1R 6V6, Canada | |
Completed | Taipei, 100, Taiwan | |
Completed | Taipei, 11217, Taiwan | |
Completed | Taoyuan, 33305, Taiwan | |
Completed | Kaohsiung, 813, Taiwan | |
Withdrawn | Zürich, 8091, Switzerland | |
Completed | Newark, 07103, United States | |
Completed | Iowa City, 52242, United States | |
Withdrawn | PARIS CEDEX 15, 75908, France | |
Completed | PESSAC, 33604, France | |
Withdrawn | BREST, 29609, France | |
Withdrawn | Lille Cedex, 59037, France | |
Completed | Rouen, 76031, France | |
Completed | TOULOUSE, 31403, France | |
Withdrawn | PARIS cedex 10, 75475, France | |
Completed | Örebro, 701 85, Sweden | |
Completed | Toyama, 930-8550, Japan | |
Withdrawn | Omaha, 68131, United States | |
Completed | Chicago, 60611-2908, United States | |
Completed | AMSTERDAM, 1105 AZ, Netherlands | |
Completed | Minato-ku, 106-0031, Japan | |
Completed | Yokosuka, 238-8567, Japan | |
Completed | Sakai, 599-8247, Japan | |
Withdrawn | Yao, 581-0011, Japan | |
Completed | Iizuka, 820-8505, Japan | |
Completed | Zrifin, 7030000, Israel | |
Completed | Jerusalem, 9103102, Israel | |
Completed | Praha 4, 140 21, Czechia | |
Completed | Macon, 31201, United States | |
Withdrawn | Aarhus N, 8200, Denmark | |
Withdrawn | Wilmington, 19803, United States | |
Completed | Minneapolis, 55422, United States | |
Completed | GENT, 9000, Belgium | |
Completed | Kromeriz, 767 01, Czechia | |
Completed | Charleston, 29425, United States | |
Withdrawn | Jacksonville, 32209, United States | |
Completed | New Orleans, 70112-1396, United States | |
Completed | Germantown, 38138, United States | |
Completed | Stevenage, SG1 4AB, United Kingdom | |
Withdrawn | Northampton, NN1 5BD, United Kingdom | |
Completed | Chesterfield, S44 5DX, United Kingdom | |
Completed | Brisbane, 4029, Australia | |
Completed | Hobart, 7000, Australia | |
Withdrawn | Prahran, 3181, Australia | |
Completed | DARLINGHURST, 2010, Australia | |
Completed | Ft. Lauderdale, 33308, United States | |
Completed | Jackson, 39216-4505, United States | |
Completed | HUY, 4500, Belgium | |
Completed | Sofia, 1527, Bulgaria | |
Completed | Saint-Jean-sur-Richelieu, J3A 1C3, Canada | |
Completed | Montreal, H2W 1T8, Canada | |
Withdrawn | IEPER, 8900, Belgium | |
Completed | Sofia, 1202, Bulgaria | |
Completed | Sofia, 1309, Bulgaria | |
Completed | Sofia, 1233, Bulgaria | |
Completed | Stara Zagora, 6000, Bulgaria | |
Completed | Seoul, 138-736, Korea, Republic Of | |
Withdrawn | Shanghai, 200025, China | |
Withdrawn | Frankfurt, 60596, Germany | |
Completed | Haifa, 3109601, Israel | |
Completed | Tiberias, 1528001, Israel | |
Withdrawn | Ureshino, 843-0393, Japan | |
Withdrawn | Seoul, 06351, Korea, Republic Of | |
Withdrawn | Seoul, 03722, Korea, Republic Of | |
Completed | Takamatsu, 760-0018, Japan | |
Completed | Montreal, H1T 1C8, Canada | |
Withdrawn | Groningen, 9713 GZ, Netherlands | |
Completed | Linz, 4020, Austria | |
Completed | El Palmar, 30120, Spain | |
Completed | Valencia, 46010, Spain | |
Completed | Naha, 902-8511, Japan | |
Completed | Naples, 34102, United States | |
Completed | Arezzo, 52044, Italy | |
Completed | Bergamo, 24127, Italy | |
Completed | Milano, 20149, Italy | |
Completed | Bad Krozingen, 79189, Germany | |
Withdrawn | Sofia, 1431, Bulgaria | |
Completed | Burgas, 8018, Bulgaria | |
Withdrawn | VELDHOVEN, 5504 DB, Netherlands | |
Withdrawn | HOORN, 1624 NP, Netherlands | |
Completed | Redcliffe, 4020, Australia | |
Completed | Brisbane, 4064, Australia | |
Withdrawn | Fairfield, 45014, United States | |
Withdrawn | Liestal, 4410, Switzerland | |
Completed | BRON Cedex, 69677, France | |
Completed | Krakow, 31-121, Poland | |
Completed | Szczecin, 70-965, Poland | |
Completed | Holbaek, 4300, Denmark | |
Withdrawn | Slany, 274 01, Czechia | |
Completed | Hannover, 30625, Germany | |
Withdrawn | LA TRONCHE, 38700, France | |
Completed | Linz, 4010, Austria | |
Completed | Bad Homburg, 61348, Germany | |
Completed | Randers, 8930, Denmark | |
Withdrawn | Wien, 1100, Austria | |
Completed | Chaidari, 12462, Greece | |
Completed | Athens, 11527, Greece | |
Completed | Nea Ionia / Athens, 142 33, Greece | |
Completed | New Taipei City, 220, Taiwan | |
Withdrawn | Hodmezovasarhely, 6800, Hungary | |
Completed | Lisboa, 1449-005, Portugal | |
Completed | Lisboa, 1500-650, Portugal | |
Completed | Almada, 2801-951, Portugal | |
Completed | Lisboa, 1649-035, Portugal | |
Completed | Uji, 611-0041, Japan | |
Withdrawn | Dimitrovgrad, 6400, Bulgaria | |
Completed | Osaka, 558-8558, Japan | |
Withdrawn | Toyota, 471-8513, Japan | |
Withdrawn | Gifu, 500-8717, Japan | |
Completed | Higashiibaraki, 311-3193, Japan |
Primary Outcome
- Change of log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP)date_rangeTime Frame:Baseline and 12 weeksenhanced_encryptionNoSafety Issue:
- Change of left atrial volume (LAV)date_rangeTime Frame:Baseline and 12 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 4 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
5