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Zilebesiran for High Blood Pressure (KARDIA-3 Trial)

Phase 2
Recruiting
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and months 3 and 6
Awards & highlights

KARDIA-3 Trial Summary

This trial aims to see if adding zilebesiran to the treatment of patients with high cardiovascular risk and high blood pressure, that is not well controlled with usual medications, can improve their condition.

Who is the study for?
This trial is for adults with high blood pressure not well-managed by 2-4 standard medications and who have a history of heart disease or are at high risk for it. They should have specific blood pressure readings and a moderately reduced kidney function but not severe kidney issues.Check my eligibility
What is being tested?
The study tests Zilebesiran, added to usual blood pressure meds, against a placebo. It aims to see if Zilebesiran better controls blood pressure in those at high risk for heart problems.See study design
What are the potential side effects?
Potential side effects of Zilebesiran may include reactions at the injection site, low blood pressure, dizziness, abnormal kidney function tests, and possibly allergic reactions.

KARDIA-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and months 3 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and months 3 and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)
Secondary outcome measures
Change from Baseline Over Time in Serum Angiotensinogen (AGT)
Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM
Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM
+6 more

KARDIA-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZilebesiranExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,428 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,064,014 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants involved in this research endeavor?

"Indeed, the details provided on clinicaltrials.gov imply that this research study is currently enrolling volunteers. It was initially published on February 29th, 2024 and last revised on March 8th, 2024. The trial aims to recruit 390 participants from a single site."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"Indeed, according to the details on clinicaltrials.gov, this trial is actively enrolling participants. Initially shared on February 29th, 2024 and last revised on March 8th, 2024, the research aims to recruit a total of 390 patients from one specific site."

Answered by AI

What are the safety considerations for individuals using Zilebesiran?

"With the current Phase 2 trial status of Zilebesiran, our team rates its safety at level 2 on a scale from 1 to 3. While there is some existing data supporting its safety profile, efficacy evidence is yet to be established."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)
2024. "Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06272487.
~260 spots leftby Mar 2025
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