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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications


Description

The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

Trial Eligibility

Inclusion Criteria: * History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to \<60 mL/min/1.73m\^2 * Mean seated office SBP ≥140 mmHg and ≤170 mmHg * 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM * Must be on stable therapy with 2 to 4 classes of antihypertensive medications Exclusion Criteria: * Secondary hypertension * Orthostatic hypotension * Proteinuria \>3 g/day * Serum potassium \>4.8 milliequivalents per liter (mEq/L)

Study Info

Organization

Alnylam Pharmaceuticals


Primary Outcome

Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)


Outcome Timeframe Baseline and Month 3

NCTID NCT06272487

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-02-29

Completion Date 2025-03-20

Enrollment Target 390

Interventions

DRUG Zilebesiran

DRUG Placebo

Locations Recruiting

Clinical Trial Site

United States, Alabama, Alexander City


Clinical Trial Site

United States, Alabama, Daphne


Clinical Trial Site

United States, Alabama, Foley


Clinical Trial Site

United States, Alabama, Huntsville


Clinical Trial Site

United States, Alabama, Huntsville


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