Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02861534 | A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) | PHASE3 | COMPLETED | 5,050 | — | — | Sep 20, 2016 | Sep 2, 2019 | Nov 15, 2021 | - | — |
| NCT05714085 | Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) | PHASE2 | RECRUITING | 342 | — | — | May 31, 2023 | Apr 15, 2032 | May 29, 2026 | 106 | United States, Belgium +27 |
Time 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.
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| Vericiguat | EXPERIMENTAL | Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose will be uptitrated to 5 mg and to 10 mg. |
| Placebo | PLACEBO_COMPARATOR | Participants receive a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose will be uptitrated to 5 mg and to 10 mg. |
| Base Period: Vericiguat | EXPERIMENTAL | Participants in the Base Period receive 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks. |
| Base Period: Placebo | PLACEBO_COMPARATOR | Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks. |
| Extension Period: Vericiguat | EXPERIMENTAL | Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period. |
| Name | Type | Description |
|---|---|---|
| Vericiguat | DRUG | 2.5, 5.0, or 10.0 mg orally once daily |
| Placebo for vericiguat | DRUG | 2.5, 5.0, or 10.0 mg orally once daily |
| Vericiguat tablet | DRUG | 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form |
| Vericiguat suspension | DRUG | 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form |
| Placebo tablet | DRUG | Placebo for vericiguat administered orally once daily in tablet form |
| Placebo suspension | DRUG | Placebo for vericiguat administered orally once daily in suspension form |
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...