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

NCT06272487
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Phase
Phase 2
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Recruitment status
Completed
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Participants
375
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Lead sponsor
Alnylam Pharmaceuticals
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Start date
2024-02-29
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Number of sites
195
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Summary
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.
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Acronym
KARDIA-3
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Short title
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)
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Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-12-01
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First posted
2024-02-22
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Registry last updated
2026-03-02
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Primary completion date
2025-06-19
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Start date
2024-02-29
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Actual participants
375
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Participants
375
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
195
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Alnylam Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06272487
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ClinicalTrials.gov ID
NCT06272487
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline and Month 3

  1. Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)

    Timeframe: Baseline and Month 3

  2. Change from Baseline at Month 6 in Mean Seated Office SBP

    Timeframe: Baseline and Month 6

  3. Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM

    Timeframe: Baseline and Month 6

  4. Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6

    Timeframe: Month 6

  5. Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6

    Timeframe: Month 6

  6. Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM

    Timeframe: Baseline and Months 3 and 6

  7. Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP

    Timeframe: Baseline and Months 3 and 6

  8. Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM

    Timeframe: Baseline and Months 3 and 6

  9. Change from Baseline Over Time in Serum Angiotensinogen (AGT)

    Timeframe: Baseline through Month 6

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • Secondary hypertension
  • Orthostatic hypotension
  • Proteinuria >3 g/day
  • Serum potassium >4.8 milliequivalents per liter (mEq/L)
Sources for eligibility
clinicaltrials.gov

  • Clinical Trial SiteAlexander City, United States
  • Clinical Trial SiteDaphne, United States
  • Clinical Trial SiteFoley, United States
  • Clinical Trial SiteHuntsville, United States
  • Clinical Trial SiteHuntsville, United States
  • Clinical Trial SiteMontgomery, United States
  • Clinical Trial SiteGilbert, United States
  • Clinical Trial SitePhoenix, United States
  • Clinical Trial SiteSun City, United States
  • Clinical Trial SiteTempe, United States
  • Clinical Trial SiteTucson, United States
  • Clinical Trial SiteBeverly Hills, United States
  • Clinical Trial SiteCovina, United States
  • Clinical Trial SiteEncinitas, United States
  • Clinical Trial SiteGarden Grove, United States
  • Clinical Trial SiteHuntington Beach, United States
  • Clinical Trial SiteLos Angeles, United States
  • Clinical Trial SiteLos Angeles, United States
  • Clinical Trial SiteNorthridge, United States
  • Clinical Trial SiteNorthridge, United States
  • Clinical Trial SitePasadena, United States
  • Clinical Trial SiteSan Diego, United States
  • Clinical Trial SiteSan Diego, United States
  • Clinical Trial SiteSan Dimas, United States
  • Clinical Trial SiteSimi Valley, United States

And 170 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)