Hypertension Clinical Trial
— KARDIA-3Official 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
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.
Status | Recruiting |
Enrollment | 390 |
Est. completion date | December 19, 2025 |
Est. primary completion date | March 20, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion Criteria: - Secondary hypertension - Orthostatic hypotension - Proteinuria >3 g/day - Serum potassium >4.8 milliequivalents per liter (mEq/L) |
Country | Name | City | State |
---|---|---|---|
Canada | Clinical Trial Site | Brampton | Ontario |
Canada | Clinical Trial Site | Chicoutimi | Quebec |
Canada | Clinical Trial Site | Montréal | Quebec |
Canada | Clinical Trial Site | Sarnia | Ontario |
United States | Clinical Trial Site | Alexander City | Alabama |
United States | Clinical Trial Site | Berlin | New Jersey |
United States | Clinical Trial Site | Charlotte | North Carolina |
United States | Clinical Trial Site | Clearwater | Florida |
United States | Clinical Trial Site | Coral Gables | Florida |
United States | Clinical Trial Site | Covina | California |
United States | Clinical Trial Site | Daphne | Alabama |
United States | Clinical Trial Site | Daytona Beach | Florida |
United States | Clinical Trial Site | El Dorado | Kansas |
United States | Clinical Trial Site | Flint | Michigan |
United States | Clinical Trial Site | Foley | Alabama |
United States | Clinical Trial Site | Fort Myers | Florida |
United States | Clinical Trial Site | Garden Grove | California |
United States | Clinical Trial Site | Houston | Texas |
United States | Clinical Trial Site | Houston | Texas |
United States | Clinical Trial Site | Huntington Beach | California |
United States | Clinical Trial Site | Huntsville | Alabama |
United States | Clinical Trial Site | Jacksonville | Florida |
United States | Clinical Trial Site | Jacksonville | Florida |
United States | Clinical Trial Site | Las Vegas | Nevada |
United States | Clinical Trial Site | Miami | Florida |
United States | Clinical Trial Site | Miami | Florida |
United States | Clinical Trial Site | Miami | Florida |
United States | Clinical Trial Site | Monroe | North Carolina |
United States | Clinical Trial Site | New Orleans | Louisiana |
United States | Clinical Trial Site | Newton | Kansas |
United States | Clinical Trial Site | Norman | Oklahoma |
United States | Clinical Trial Site | North Miami Beach | Florida |
United States | Clinical Trial Site | Northridge | California |
United States | Clinical Trial Site | Northridge | California |
United States | Clinical Trial Site | Orlando | Florida |
United States | Clinical Trial Site | Owensboro | Kentucky |
United States | Clinical Trial Site | Pasadena | California |
United States | Clinical Trial Site | Phoenix | Arizona |
United States | Clinical Trial Site | Rapid City | South Dakota |
United States | Clinical Trial Site | San Antonio | Texas |
United States | Clinical Trial Site | Santa Ana | California |
United States | Clinical Trial Site | Savannah | Georgia |
United States | Clinical Trial Site | Sherman | Texas |
United States | Clinical Trial Site | Splendora | Texas |
United States | Clinical Trial Site | Stephenville | Texas |
United States | Clinical Trial Site | Tempe | Arizona |
United States | Clinical Trial Site | Tomball | Texas |
United States | Clinical Trial Site | Washington | District of Columbia |
United States | Clinical Trial Site | West Hills | California |
United States | Clinical Trial Site | Wichita | Kansas |
United States | Clinical Trial Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Alnylam Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) | Baseline and Month 3 | ||
Secondary | Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) | Baseline and Month 3 | ||
Secondary | Change from Baseline at Month 6 in Mean Seated Office SBP | Baseline and Month 6 | ||
Secondary | Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM | Baseline and Month 6 | ||
Secondary | Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction =10 mmHg without Intensification of Antihypertensive Regimen at Month 6 | Month 6 | ||
Secondary | 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 | Month 6 | ||
Secondary | Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM | Baseline and Months 3 and 6 | ||
Secondary | Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP | Baseline and Months 3 and 6 | ||
Secondary | Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM | Baseline and Months 3 and 6 | ||
Secondary | Change from Baseline Over Time in Serum Angiotensinogen (AGT) | Baseline through Month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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