Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) (KARDIA-2)
Hypertension

About this trial
This is an interventional treatment trial for Hypertension focused on measuring High blood pressure, Hypertension, Hypertensive, siRNA, Angiotensinogen, AGT
Eligibility Criteria
Inclusion Criteria:
Office SBP at Screening as follows:
- ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension
- ≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications
- 24-hour mean SBP >130 mmHg and ≤160 mmHg by ABPM after at least 4 weeks of run-in
Exclusion Criteria:
- Secondary hypertension, orthostatic hypotension
- Elevated potassium >5 mEq/L
- Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2
- Received an investigational agent within the last 30 days
- Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
- History of any cardiovascular event within 6 months prior to randomization
- History of intolerance to SC injection(s)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Zilebesiran (Add-on to Olmesartan)
Placebo (Add-on to Olmesartan)
Zilebesiran (Add-on to Amlodipine)
Placebo (Add-on to Amlodipine)
Zilebesiran (Add-on to Indapamide)
Placebo (Add-on to Indapamide)
Following a run-in on olmesartan, eligible participants will receive zilebesiran on Day 1 of a 6-month double-blind treatment period as add-on to olmesartan. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Following a run-in on olmesartan, eligible participants will receive placebo on Day 1 of a 6-month double-blind treatment period as add-on to olmesartan. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Following a run-in on amlodipine, eligible participants will receive zilebesiran on Day 1 of a 6-month double-blind treatment period as add-on to amlodipine. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Following a run-in on amlodipine, eligible participants will receive placebo on Day 1 of a 6-month double-blind treatment period as add-on to amlodipine. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Following a run-in on indapamide, eligible participants will receive zilebesiran on Day 1 of a 6-month double-blind treatment period as add-on to indapamide. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Following a run-in on indapamide, eligible participants will receive placebo on Day 1 of a 6-month double-blind treatment period as add-on to indapamide. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.