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

NCT05103332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2025-11-03

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Indapamide

Indapamide administered orally

DRUG

Amlodipine

Amlodipine administered orally

DRUG

Olmesartan

Olmesartan administered orally

DRUG

Placebo

Placebo administered by SC injection

DRUG

Zilebesiran

Zilebesiran administered by SC injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2023-12-11
Completion
2024-09-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Estonia
  • Germany
  • Latvia
  • Lithuania
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103332 on ClinicalTrials.gov