Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)

Conditions

• High Cardiovascular Risk
• Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zilebesiran — DRUG
  Zilebesiran administered by subcutaneous (SC) injection
• Placebo — DRUG
  Placebo administered by SC injection

Study Details

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.

Key Dates

Start date

Feb 29, 2024

Status verified

Feb 2026

Primary completion

Jun 19, 2025

Completion

Dec 1, 2025

Study Design

Enrollment

375 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zilebesiran
  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.
• Placebo Comparator: Placebo
  Participants will receive placebo on Day 1 of the 6-month 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.

Primary Outcome Measure

Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 3 ]

Locations (139)

Find similar trials in Alexander City, AL

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