Trial Condition(s):
Heart Failure, Chronic heart failure with reduced ejection fraction
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) (VICTORIA)
Bayer Identifier:
16493
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- History of chronic HF (New York Heart Association [NYHA] Class II-IV) on standard therapy before qualifying HF decompensation - Previous HF hospitalization within 6 months prior to randomization or intravenous (IV) diuretic treatment for HF (without hospitalization) within 3 months. - Brain natriuretic peptide (BNP) levels: sinus rhythm-≥ 300 pg/mL; atrial fibrillation-≥ 500 pg/mL and Nterminal pro-Brain Natriuretic Peptide (NT proBNP) levels: sinus rhythm- ≥ 1000 pg/mL; atrial fibrillation - ≥ 1600 pg/mL within 30 days prior to randomization - Left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization by any method If female, is not of reproductive potential or agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: practice abstinence from heterosexual activity or use (or have her partner use) acceptable contraception during heterosexual activity.
Exclusion Criteria
- Clinically unstable at the time of randomization as defined by either the administration of any IV treatment within 24 hours prior to randomization, and/or systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension - Current or anticipated use of long-acting nitrates or nitric oxide (NO) donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine - Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil - Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat - Known allergy or sensitivity to any sGC stimulator - Awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates receiving an implanted ventricular assist device - Primary valvular heart disease requiring surgery or intervention, or is within 3 months after valvular surgery or intervention - Hypertrophic obstructive cardiomyopathy - Acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy - Post-heart transplant cardiomyopathy - Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia - Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [(STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) within 60 days, or indication for coronary revascularization at time of randomization - Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days - Complex congenital heart disease - Active endocarditis or constrictive pericarditis - Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis - Severe hepatic insufficiency such as with hepatic encephalopathy - Malignancy or other non-cardiac condition limiting life expectancy to <3 years - Require continuous home oxygen for severe pulmonary disease - Current alcohol and/or drug abuse
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Morioka, Japan, 020-0066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sendai, Japan, 983-8512 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Funabashi, Japan, 273-8588 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Itabashi-ku, Japan, 173-8610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meguro-ku, Japan, 153-0051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ota-ku, Japan, 143-8541 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 227-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shizuoka, Japan, 420-8527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 464-8547 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 457-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 601-1495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 530-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hirakata, Japan, 573-0153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-0862 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsue, Japan, 690-8509 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okayama, Japan, 700-8557 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanonji, Japan, 769-1695 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 800-0296 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagasaki, Japan, 852-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miyazaki, Japan, 880-2102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sayama, Japan, 350-1305 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 252-5188 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uji, Japan, 611-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 543-0035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naha, Japan, 902-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wako, Japan, 351-0102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 222-0036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 564-8565 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kishiwada, Japan, 596-0042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takarazuka, Japan, 665-0873 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamada, Japan, 697-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 805-8508 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kagoshima, Japan, 892-0822 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meguro-ku, Japan, 152-8902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koga, Japan, 306-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adachi-ku, Japan, 123-0845 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shibuya-ku, Japan, 150-0013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 160-0023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hachioji, Japan, 192-0918 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinagawa-ku, Japan, 141-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawasaki, Japan, 211-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 247-8581 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyama, Japan, 930-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyama, Japan, 930-0194 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 454-8502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 460-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 602-8026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Higashiosaka, Japan, 578-8588 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takarazuka, Japan, 665-0022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurume, Japan, 830-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shimotsuke, Japan, 329-0498 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawasaki, Japan, 211-8533 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 232-0024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 602-8566 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 654-0026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Funabashi, Japan, 274-8503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsudo, Japan, 270-2251 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takatsuki, Japan, 569-1096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 655-0017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsuyama, Japan, 790-0062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02114-2696 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 252-0375 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Longueuil, Canada, J4N 1E1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 194354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S44 5DX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Juan, Puerto Rico, 00921 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS cedex 10, France, 75475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-981 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site El Palmar (Murcia), Spain, 30120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SNEEK, Netherlands, 8601 ZK | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Malmö, Sweden, 205 02 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Svendborg, Denmark, DK-5700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oslo, Norway, 0424 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 4, Czech Republic, 140 21 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kistarcsa, Hungary, 2143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Istanbul, Turkey, 34304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alexandroupoli, Greece, 68100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 02841 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lausanne, Switzerland, 1011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Espoo, Finland, 02740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sarawak, Malaysia, 93400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Christchurch, New Zealand, 8140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland, DUBLIN 4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Querétaro, Mexico, 76000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Murdoch, Australia, 6150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mar del Plata, Argentina, B7600FZN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manila, Philippines, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aki-gun, Japan, 735-8585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 654-0155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tachikawa, Japan, 190-0014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Niigata, Japan, 950-2087 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iwakuni, Japan, 740-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nakagami-gun, Japan, 901-2393 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koshigaya, Japan, 343-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagano, Japan, 388-8004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagasaki, Japan, 850-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oita, Japan, 870-0192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shobara, Japan, 727-0013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yonago, Japan, 683-8605 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagaoka, Japan, 940-8621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Ukraine | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Peru | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Guatemala | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT GlObal Study in Subjects With Heart Failure With Reduced EjectIon FrAction (VICTORIA)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Additional Information
Not Available
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