Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zilebesiran · 3 trials · 4 indications
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Zilebesiran 300 mg | EXPERIMENTAL | Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications. |
| Zilebesiran | EXPERIMENTAL | Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period. |
| Name | Type | Description |
|---|---|---|
| Zilebesiran | DRUG | Zilebesiran will be administered SC |
| Placebo | DRUG | Placebo will be administered SC |
Inclusion Criteria: * Is 18 years or older for patients with established cardiovascular disease (CVD) * Is 55 years or older for patients with high risk for CVD * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD * Has treated hypertension...