Phase
Condition
Hyponatremia
Congestive Heart Failure
Chest Pain
Treatment
Vericiguat tablet
Vericiguat suspension
Clinical Study ID
Ages > 1 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Was randomized, received at least 1 dose of study intervention (vericiguat orplacebo), and completed the Week 52 visit and safety follow-up period for the VALORbase study.
A participant assigned female sex at birth is not pregnant or breastfeeding, and isnot a participant/participants of childbearing potential (POCBP) or is a POCBP whoUses a contraceptive method that is highly effective, has a negative highlysensitive pregnancy test, abstains from breastfeeding during the study interventionperiod and for at least 30 days after study intervention., and whose medicalhistory, menstrual history, and recent sexual activity has been reviewed by theinvestigator to decrease the risk for inclusion of a POCBP with an early undetectedpregnancy.
Is able to receive medication via the oral or gastric route .
Exclusion
Exclusion Criteria:
Is hypotensive for age at Visit 1
Has a known allergy or sensitivity to vericiguat, any of its constituents, or anyother soluble guanylate cyclase (sGC )stimulator.
Has undergone heart transplantation or has an implanted ventricular assist device.
Has severe chronic kidney disease
Has hepatic disorder
Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitorsduring the study.
Has concurrent or anticipated use of an sGC stimulator.
Is both ≥18 years of age and vericiguat is commercially available to the participant
Study Design
Connect with a study center
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607)
Rionegro, Antioquia 054040
ColombiaSite Not Available
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607)
Rionegro 3670730, Antioquia 3689815 054040
ColombiaSite Not Available
Fundacion Valle del Lili- CIC ( Site 0604)
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
Fundacion Valle del Lili- CIC ( Site 0604)
Santiago de Cali 3687925, Valle del Cauca Department 3666313 760032
ColombiaSite Not Available
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest, 1096
HungarySite Not Available
Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
Budapest 3054643, 1096
HungarySite Not Available
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin, D12 N512
IrelandSite Not Available
Children's Health Ireland (CHI) at Crumlin ( Site 1400)
Dublin 2964574, D12 N512
IrelandSite Not Available
Faculty of Medicine Siriraj Hospital ( Site 3200)
Thailand, Bangkok 1609348 10700
ThailandSite Not Available
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai, 50200
ThailandSite Not Available
Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Chiang Mai 1153671, 50200
ThailandSite Not Available
Le Bonheur Children's Hospital ( Site 0007)
Memphis, Tennessee 38103
United StatesSite Not Available
Le Bonheur Children's Hospital ( Site 0007)
Memphis 4641239, Tennessee 4662168 38103
United StatesSite Not Available

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