check_circleStudy Completed
Heart failure, Chronic heart failure with reduced ejection fraction
Bayer Identifier:
16493
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) (VICTORIA)
Trial purpose
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
5050Trial Dates
September 2016 - September 2019Phase
Phase 3Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Sapporo, 060-0004, Japan | |
Completed | Morioka, 020-0066, Japan | |
Completed | Sendai, 983-8512, Japan | |
Completed | Funabashi, 273-8588, Japan | |
Completed | Itabashi-ku, 173-8610, Japan | |
Completed | Meguro-ku, 153-0051, Japan | |
Completed | Ota-ku, 143-8541, Japan | |
Completed | Yokohama, 227-8501, Japan | |
Completed | Fukui, 910-8526, Japan | |
Completed | Shizuoka, 420-8527, Japan | |
Completed | Nagoya, 464-8547, Japan | |
Completed | Nagoya, 457-8510, Japan | |
Completed | Kyoto, 601-1495, Japan | |
Completed | Osaka, 530-0001, Japan | |
Completed | Hirakata, 573-0153, Japan | |
Completed | Suita, 565-0862, Japan | |
Completed | Matsue, 690-8509, Japan | |
Completed | Okayama, 700-8557, Japan | |
Withdrawn | Hatsukaichi, 738-8503, Japan | |
Completed | Kanonji, 769-1695, Japan | |
Completed | Kitakyushu, 800-0296, Japan | |
Completed | Nagasaki, 852-8501, Japan | |
Completed | Miyazaki, 880-2102, Japan | |
Completed | Sayama, 350-1305, Japan | |
Completed | Sayama, 350-1305, Japan | |
Completed | Sagamihara, 252-5188, Japan | |
Completed | Uji, 611-0041, Japan | |
Completed | Osaka, 543-0035, Japan | |
Withdrawn | Wakayama, 640-8505, Japan | |
Completed | Naha, 902-8511, Japan | |
Completed | Wako, 351-0102, Japan | |
Completed | Bunkyo-ku, 113-8431, Japan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Yokohama, 222-0036, Japan | |
Completed | Suita, 564-8565, Japan | |
Withdrawn | Osaka, 530-8480, Japan | |
Completed | Kishiwada, 596-0042, Japan | |
Completed | Takarazuka, 665-0873, Japan | |
Completed | Hamada, 697-8511, Japan | |
Completed | Kitakyushu, 805-8508, Japan | |
Withdrawn | Kitakyushu, 802-8517, Japan | |
Withdrawn | Kagoshima, 892-0822, Japan | |
Completed | Kagoshima, 892-0822, Japan | |
Completed | Meguro-ku, 152-8902, Japan | |
Completed | Koga, 306-0041, Japan | |
Completed | Adachi-ku, 123-0845, Japan | |
Completed | Shibuya-ku, 150-0013, Japan | |
Completed | Shinjuku-ku, 160-0023, Japan | |
Completed | Hachioji, 192-0918, Japan | |
Completed | Shinagawa-ku, 141-0001, Japan | |
Completed | Kawasaki, 211-8510, Japan | |
Completed | Yokohama, 247-8581, Japan | |
Completed | Toyama, 930-8550, Japan | |
Completed | Toyama, 930-0194, Japan | |
Completed | Kanazawa, 920-8530, Japan | |
Withdrawn | Fukui, 918-8503, Japan | |
Completed | Nagoya, 454-8502, Japan | |
Withdrawn | Nagoya, 453-8511, Japan | |
Completed | Nagoya, 460-0001, Japan | |
Completed | Kyoto, 602-8026, Japan | |
Completed | Osaka, 558-8558, Japan | |
Completed | Higashiosaka, 578-8588, Japan | |
Completed | Suita, 565-0871, Japan | |
Completed | Kobe, 650-0047, Japan | |
Completed | Takarazuka, 665-0022, Japan | |
Withdrawn | Onomichi, 722-8508, Japan | |
Completed | Kurume, 830-8543, Japan | |
Withdrawn | Kumamoto, 860-0008, Japan | |
Completed | Shimotsuke, 329-0498, Japan | |
Completed | Kawasaki, 211-8533, Japan | |
Completed | Yokohama, 232-0024, Japan | |
Withdrawn | Toyoake, 470-1192, Japan | |
Completed | Kyoto, 602-8566, Japan | |
Completed | Kobe, 654-0026, Japan | |
Withdrawn | Kakegawa, 436-8555, Japan | |
Completed | Fukuoka, 812-8582, Japan | |
Completed | Funabashi, 274-8503, Japan | |
Completed | Matsudo, 270-2251, Japan | |
Completed | Takatsuki, 569-1096, Japan | |
Completed | Kobe, 655-0017, Japan | |
Completed | Matsuyama, 790-0062, Japan | |
Completed | Nahariya, 2210001, Israel | |
Completed | Frankfurt, 60596, Germany | |
Completed | Boston, 02114-2696, United States | |
Completed | Sagamihara, 252-0375, Japan | |
Completed | Longueuil, J4N 1E1, Canada | |
Completed | Graz, 8036, Austria | |
Completed | St. Petersburg, 194354, Russian Federation | |
Completed | Chesterfield, S44 5DX, United Kingdom | |
Completed | San Juan, 00921, Puerto Rico | |
Completed | PARIS cedex 10, 75475, France | |
Completed | Wroclaw, 50-981, Poland | |
Completed | Bergamo, 24127, Italy | |
Completed | El Palmar (Murcia), 30120, Spain | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | SNEEK, 8601 ZK, Netherlands | |
Completed | Malmö, 205 02, Sweden | |
Completed | Svendborg, DK-5700, Denmark | |
Completed | Oslo, 0424, Norway | |
Completed | Praha 4, 140 21, Czechia | |
Completed | Kistarcsa, 2143, Hungary | |
Completed | Istanbul, 34304, Turkey | |
Completed | Alexandroupoli, 68100, Greece | |
Completed | Seoul, 02841, Korea, Republic Of | |
Completed | Lausanne, 1011, Switzerland | |
Completed | Espoo, 02740, Finland | |
Completed | Taipei, 11217, Taiwan | |
Completed | Sarawak, 93400, Malaysia | |
Completed | Singapore, 119074, Singapore | |
Completed | Christchurch, 8140, New Zealand | |
Completed | Dublin, DUBLIN 4, Ireland | |
Completed | Querétaro, 76000, Mexico | |
Completed | Johannesburg, 2157, South Africa | |
Completed | Murdoch, 6150, Australia | |
Completed | Mar del Plata, B7600FZN, Argentina | |
Completed | Chile | |
Completed | Colombia | |
Withdrawn | Brazil | |
Completed | Hong Kong, Hong Kong | |
Completed | Manila, 1000, Philippines | |
Completed | Kashihara, 634-8522, Japan | |
Completed | Aki-gun, 735-8585, Japan | |
Completed | Kobe, 654-0155, Japan | |
Completed | Tachikawa, 190-0014, Japan | |
Completed | Niigata, 950-2087, Japan | |
Completed | Higashiibaraki, 311-3193, Japan | |
Completed | Kanazawa, 920-8650, Japan | |
Completed | Iwakuni, 740-8510, Japan | |
Completed | Shinjuku-ku, 162-8666, Japan | |
Completed | Nakagami-gun, 901-2393, Japan | |
Withdrawn | Sapporo, 060-0031, Japan | |
Withdrawn | Sapporo, 060-0031, Japan | |
Completed | Koshigaya, 343-8555, Japan | |
Completed | Nagano, 388-8004, Japan | |
Completed | Nagasaki, 850-8555, Japan | |
Completed | Oita, 870-0192, Japan | |
Completed | Shobara, 727-0013, Japan | |
Completed | Yonago, 683-8605, Japan | |
Completed | Nagaoka, 940-8621, Japan | |
Completed | China | |
Completed | Ukraine | |
Completed | Peru | |
Completed | Guatemala |
Primary Outcome
- Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) HospitalizationTime to First Occurrence of Composite Endpoint of CV Death or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization or CV death event at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A clinical events committee (CEC) reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Secondary Outcome
- Time to the First Occurrence of CV DeathTime to First Occurrence of CV Death was analyzed using a one-sided stratified log-rank test. Randomized participants without a CV death at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Time to the First Occurrence of HF HospitalizationTime to the First Occurrence of HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Time to Total HF Hospitalizations (Including First and Recurrent Events)Time to Total HF Hospitalizations (including first and recurring) was analyzed using an Andersen-Gill model. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years of follow-up) is provided.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF HospitalizationTime to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event or HF hospitalization at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18- June-2019)
- Time to All-Cause MortalityTime to All-Cause Mortality was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results: the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Number of Participants Who Experienced One or More Adverse EventsAn adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Number of Participants Who Discontinued Treatment Due to an Adverse EventAn adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Percentage of Participants Who Experienced Symptomatic HypotensionStudy participants were monitored for symptomatic hypotension, an event of clinical interest, and results were reported.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
- Percentage of Participants Who Experienced SyncopeStudy participants were monitored for syncope, an event of clinical interest, and results were reported.date_rangeTime Frame:Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2