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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06272487




Registration number
NCT06272487
Ethics application status
Date submitted
15/02/2024
Date registered
22/02/2024

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
ALN-AGT01-007
Universal Trial Number (UTN)
Trial acronym
KARDIA-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Cardiovascular Risk 0 0
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zilebesiran
Treatment: Drugs - Placebo

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.


Treatment: Drugs: Zilebesiran
Zilebesiran administered by subcutaneous (SC) injection

Treatment: Drugs: Placebo
Placebo administered by SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)
Timepoint [1] 0 0
Baseline and Month 3
Secondary outcome [1] 0 0
Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
Timepoint [1] 0 0
Baseline and Month 3
Secondary outcome [2] 0 0
Change from Baseline at Month 6 in Mean Seated Office SBP
Timepoint [2] 0 0
Baseline and Month 6
Secondary outcome [3] 0 0
Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM
Timepoint [3] 0 0
Baseline and Month 6
Secondary outcome [4] 0 0
Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction =10 mmHg without Intensification of Antihypertensive Regimen at Month 6
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Month 6
Secondary outcome [6] 0 0
Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM
Timepoint [6] 0 0
Baseline and Months 3 and 6
Secondary outcome [7] 0 0
Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP
Timepoint [7] 0 0
Baseline and Months 3 and 6
Secondary outcome [8] 0 0
Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM
Timepoint [8] 0 0
Baseline and Months 3 and 6
Secondary outcome [9] 0 0
Change from Baseline Over Time in Serum Angiotensinogen (AGT)
Timepoint [9] 0 0
Baseline through Month 6

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Secondary hypertension
* Orthostatic hypotension
* Proteinuria >3 g/day
* Serum potassium >4.8 milliequivalents per liter (mEq/L)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Clinical Trial Site - Bruce
Recruitment hospital [2] 0 0
Clinical Trial Site - Sydney
Recruitment hospital [3] 0 0
Clinical Trial Site - Brookvale
Recruitment hospital [4] 0 0
Clinical Trial Site - Concord
Recruitment hospital [5] 0 0
Clinical Trial Site - Kanwal
Recruitment hospital [6] 0 0
Clinical Trial Site - Kogarah
Recruitment hospital [7] 0 0
Clinical Trial Site - Sherwood
Recruitment hospital [8] 0 0
Clinical Trial Site - Sippy Downs
Recruitment hospital [9] 0 0
Clinical Trial Site - Garran
Recruitment hospital [10] 0 0
Clinical Trial Site - Perth
Recruitment postcode(s) [1] 0 0
- Bruce
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brookvale
Recruitment postcode(s) [4] 0 0
- Concord
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- Kanwal
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Sherwood
Recruitment postcode(s) [8] 0 0
- Sippy Downs
Recruitment postcode(s) [9] 0 0
- Garran
Recruitment postcode(s) [10] 0 0
- Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Pickering

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alnylam Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Alnylam Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alnylam Clinical Trial Information Line
Address 0 0
Country 0 0
Phone 0 0
1-877-ALNYLAM
Fax 0 0
Email 0 0
clinicaltrials@alnylam.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the United States (US) and/or the European Union (EU).

Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Requests for access to data can be submitted via the website www.vivli.org.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06272487