Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
About the study
The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
Exclusion Criteria:
- Secondary hypertension, orthostatic hypotension
- Elevated potassium >5 milliequivalents per liter (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, or laboratory evidence of diabetes during screening without known diagnosis of diabetes
- History of any cardiovascular event within 6 months prior to randomization
- History of intolerance to SC injection(s)
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Hypertension
Age (in years)
18 - 75
Phase
PHASE2
Participants Needed
672
Est. Completion Date
Sep 13, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Alnylam Pharmaceuticals
ClinicalTrials.gov NCT Identifier
NCT05103332
Study Number
ALN-AGT01-003
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