Hypertension Clinical Trial
— KARDIA-2Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication
| Verified date | May 2024 |
| Source | Alnylam Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 672 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | September 18, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Office SBP at Screening as follows: 1. =155 mmHg and =180 mmHg for patients with untreated hypertension 2. =145 mmHg and =180 mmHg for patients on antihypertensive medications - 24-hour mean SBP =130 mmHg and =160 mmHg by ABPM after at least 4 weeks of run-in Exclusion Criteria: - Secondary hypertension, orthostatic hypotension - Elevated potassium >5 milliequivalents per liter (mEq/L) - Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2 - Received an investigational agent within the last 30 days - Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, or laboratory evidence of diabetes during screening without known diagnosis of diabetes - History of any cardiovascular event within 6 months prior to randomization - History of intolerance to SC injection(s) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Clinical Trial Site | Brampton | Ontario |
| Canada | Clinical Trial Site | Burlington | Ontario |
| Canada | Clinical Trial Site | Calgary | Alberta |
| Canada | Clinical Trial Site | Chicoutimi | Quebec |
| Canada | Clinical Trial Site | Concord | Ontario |
| Canada | Clinical Trial Site | Etobicoke | Ontario |
| Canada | Clinical Trial Site | Lévis | Quebec |
| Canada | Clinical Trial Site | London | Ontario |
| Canada | Clinical Trial Site | Pointe-Claire | Quebec |
| Canada | Clinical Trial Site | Québec | Quebec |
| Canada | Clinical Trial Site | Québec | |
| Canada | Clinical Trial Site | Scarborough | Ontario |
| Canada | Clinical Trial Site | Scarborough | Ontario |
| Canada | Clinical Trial Site | Sherbrooke | Quebec |
| Canada | Clinical Trial Site | Toronto | Ontario |
| Canada | Clinical Trial Site | Toronto | Ontario |
| Canada | Clinical Trial Site | Trois-Rivières | Quebec |
| Canada | Clinical Trial Site | Victoriaville | Quebec |
| Canada | Clinical Trial Site | Winnipeg | Ontario |
| Estonia | Clinical Trial Site | Tallin | |
| Estonia | Clinical Trial Site | Tallinn | |
| Estonia | Clinical Trial Site | Tallinn | |
| Estonia | Clinical Trial Site | Tartu | |
| Germany | Clinical Trial Site | Berlin | |
| Germany | Clinical Trial Site | Frankfurt | |
| Latvia | Clinical Trial Site | Daugavpils | |
| Latvia | Clinical Trial Site | Kuldiga | |
| Latvia | Clinical Trial Site | Riga | |
| Lithuania | Clinical Trial Site | Kaunas | |
| Lithuania | Clinical Trial Site | Kaunas | |
| Lithuania | Clinical Trial Site | Panevežys | |
| Lithuania | Clinical Trial Site | Vilnius | |
| Poland | Clinical Trial Site | Czestochowa | |
| Poland | Clinical Trial Site | Gdansk | |
| Poland | Clinical Trial Site | Gdynia | |
| Poland | Clinical Trial Site | Katowice | |
| Poland | Clinical Trial Site | Poznan | |
| Poland | Clinical Trial Site | Staszów | |
| Poland | Clinical Trial Site | Warszawa | |
| Poland | Clinical Trial Site | Wroclaw | |
| Poland | Clinical Trial Site | Zamosc | |
| Puerto Rico | Clinical Trial Site | Bayamón | |
| Puerto Rico | Clinical Trial Site | Manatí | |
| Puerto Rico | Clinical Trial Site | Ponce | |
| United Kingdom | Clinical Trial Site | Bellshill | Lanarkshire |
| United Kingdom | Clinical Trial Site | Carshalton | Surrey |
| United Kingdom | Clinical Trial Site | Carshalton | |
| United Kingdom | Clinical Trial Site | Chelmsford | |
| United Kingdom | Clinical Trial Site | Chorley | |
| United Kingdom | Clinical Trial Site | Dundee | |
| United Kingdom | Clinical Trial Site | Edinburgh | |
| United Kingdom | Clinical Trial Site | Enfield | |
| United Kingdom | Clinical Trial Site | Fowey | |
| United Kingdom | Clinical Trial Site | Glasgow | |
| United Kingdom | Clinical Trial Site | Hexham | |
| United Kingdom | Clinical Trial Site | Lancashire Preston | |
| United Kingdom | Clinical Trial Site | Leicester | |
| United Kingdom | Clinical Trial Site | Leicestershire | |
| United Kingdom | Clinical Trial Site | Liskeard | |
| United Kingdom | Clinical Trial Site | London | |
| United Kingdom | Clinical Trial Site | Manchester | |
| United Kingdom | Clinical Trial Site | Newquay | |
| United Kingdom | Clinical Trial Site | Plymouth | |
| United Kingdom | Clinical Trial Site | Sheffield | |
| United Kingdom | Clinical Trial Site | Torpoint | |
| United Kingdom | Clinical Trial Site | Wiltshire | |
| United States | Clinical Trial Site | Acworth | Georgia |
| United States | Clinical Trial Site | Amarillo | Texas |
| United States | Clinical Trial Site | Bakersfield | California |
| United States | Clinical Trial Site | Baltimore | Maryland |
| United States | Clinical Trial Site | Bell Gardens | California |
| United States | Clinical Trial Site | Berwyn | Illinois |
| United States | Clinical Trials Site | Beverly Hills | California |
| United States | Clinical Trial Site | Birmingham | Alabama |
| United States | Clinical Trial Site | Bossier City | Louisiana |
| United States | Clinical Trial Site | Bradenton | Florida |
| United States | Clinical Trial Site | Bronx | New York |
| United States | Clinical Trial Site | Burke | Virginia |
| United States | Clinical Trial Site | Canoga Park | California |
| United States | Clinical Trial Site | Canton | Georgia |
| United States | Clinical Trial Site | Carlsbad | California |
| United States | Clinical Trial Site | Carrollton | Texas |
| United States | Clinical Trial Site | Chandler | Arizona |
| United States | Clinical Trial Site | Clearwater | Florida |
| United States | Clinical Trial Site | Coconut Creek | Florida |
| United States | Clinical Trial Site | Columbus | Georgia |
| United States | Clinical Trial Site | Coppell | Texas |
| United States | Clinical Trial Site | Coral Gables | Florida |
| United States | Clinical Trial Site | Dallas | Texas |
| United States | Clinical Trial Site | Durham | North Carolina |
| United States | Clinical Trial Site | Eatonton | Georgia |
| United States | Clinical Trial Site | Encinitas | California |
| United States | Clinical Trial Site | Garden Grove | California |
| United States | Clinical Trial Site | Greensboro | North Carolina |
| United States | Clinical Trial Site | Greensboro | North Carolina |
| United States | Clinical Trial Site | Greenville | North Carolina |
| United States | Clinical Trial Site | Greenville | South Carolina |
| United States | Clinical Trial Site | Hallandale Beach | Florida |
| United States | Clinical Trial Site | Hazelwood | Missouri |
| United States | Clinical Trial Site | Henderson | Nevada |
| United States | Clinical Trial Site | Hollywood | Florida |
| United States | Clinical Trial Site | Hollywood | Florida |
| United States | Clinical Trial Site | Hollywood | 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 | Inverness | Florida |
| United States | Clinical Trial Site | Irvine | California |
| United States | Clinical Trial Site | Jackson | Mississippi |
| United States | Clinical Trial Site | Jacksonville | Florida |
| United States | Clinical Trial Site | Jacksonville | Florida |
| United States | Clinical Trial Site | Jacksonville | Florida |
| United States | Clinical Trial Site | Jefferson City | Missouri |
| United States | Clinical Trial Site | Kenosha | Wisconsin |
| United States | Clinical Trial Site | Lake City | Florida |
| United States | Clinical Trial Site | Lake Jackson | Texas |
| United States | Clinical Trial Site | Las Vegas | Nevada |
| United States | Clinical Trial Site | Little River | South Carolina |
| United States | Clinical Trial Site | Long Beach | California |
| United States | Clinical Trial Site | Long Beach | California |
| United States | Clinical Trial Site | Los Angeles | California |
| United States | Clinical Trial Site | Louisville | Kentucky |
| United States | Clinical Trial Site | Macon | Georgia |
| United States | Clinical Trials Site | Margate | Florida |
| United States | Clinical Trial Site | Marion | Ohio |
| United States | Clinical Trial Site | Medford | Oregon |
| United States | Clinical Trial Site | Memphis | Tennessee |
| United States | Clinical Trial Site | Mesa | Arizona |
| 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 | Miami | Florida |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Mission Hills | California |
| United States | Clinical Trial Site | Monroe | North Carolina |
| United States | Clinical Trial Site | Naples | Florida |
| United States | Clinical Trial Site | New Orleans | Louisiana |
| United States | Clinical Trial Site | New York | New York |
| United States | Clinical Trial Site | Norman | Oklahoma |
| United States | Clinical Trial Site | North Dartmouth | Massachusetts |
| United States | Clinical Trial Site | Oceanside | California |
| United States | Clinical Trial Site | Orlando | Florida |
| United States | Clinical Trial Site | Orlando | Florida |
| United States | Clinical Trial Site | Panorama City | California |
| United States | Clinical Trial Site | Pembroke Pines | Florida |
| United States | Clinical Trial Site | Plano | Texas |
| United States | Clinical Trial Site | Plano | Texas |
| United States | Clinical Trial Site | Pomona | California |
| United States | Clinical Trial Site | Pomona | California |
| United States | Clinical Trial Site | Prairieville | Louisiana |
| United States | Clinical Trial Site | S. Gate | California |
| United States | Clinical Trial Site | Saint Augustine | Florida |
| United States | Clinical Trial Site | Saint Louis | Missouri |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Diego | California |
| United States | Clinical Trial Site | Santa Clarita | California |
| United States | Clinical Trial Site | Savannah | Georgia |
| United States | Clinical Trial Site | Sherman | Texas |
| United States | Clinical Trial Site | Shreveport | Louisiana |
| United States | Clinical Trial Site | Southgate | Michigan |
| United States | Clinical Trial Site | Splendora | Texas |
| United States | Clinical Trial Site | Stephenville | Texas |
| United States | Clinical Trial Site | Sugar Land | Texas |
| United States | Clinical Trial Site | Tampa | Florida |
| United States | Clinical Trial Site | Tempe | Arizona |
| United States | Clinical Trial Site | Tempe | Arizona |
| United States | Clinical Trial Site | Tomball | Texas |
| United States | Clinical Trial Site | Tustin | California |
| United States | Clinical Trial Site | Upland | California |
| United States | Clinical Trial Site | Valencia | California |
| United States | Clinical Trial Site | Valparaiso | Indiana |
| United States | Clinical Trial Site | Victorville | California |
| United States | Clinical Trial Site | Vista | California |
| United States | Clinical Trial Site | Waco | Texas |
| United States | Clinical Trial Site | Washington | District of Columbia |
| United States | Clinical Trials Site | Wichita Falls | Texas |
| United States | Clinical Trial site | Winston-Salem | North Carolina |
| United States | Clinical Trial Site | Winter Haven | Florida |
| United States | Clinical Trial Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Alnylam Pharmaceuticals |
United States, Canada, Estonia, Germany, Latvia, Lithuania, Poland, Puerto Rico, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline at Month 3 in 24-Hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM) | Baseline and Month 3 | ||
| Secondary | Change from Baseline at Month 3 in Office SBP | Baseline and Month 3 | ||
| Secondary | Time-adjusted Change from Baseline through Month 6 in Office SBP and 24-hour Mean SBP, Assessed by ABPM | Baseline through Month 6 | ||
| Secondary | Proportion of Patients with 24-hour Mean SBP Assessed by ABPM <130 mmHg and/or Reduction from Baseline = 20 mmHg without Escape Antihypertensive Medication at Month 6 | Baseline and Month 6 | ||
| Secondary | Change in 24-hour Mean SBP and Diastolic Blood Pressure (DBP), Assessed by ABPM | Baseline and Month 6 | ||
| Secondary | Change in Office SBP and DBP | Baseline and Month 6 | ||
| Secondary | Change in Daytime and Nighttime Mean SBP and DBP, Assessed by ABPM | Daytime is defined as 6 am to 9:59 pm and nighttime is defined as 10 pm to 5:59 am. | Baseline and Month 6 | |
| Secondary | Change from Baseline in Serum Angiotensinogen (AGT) | Baseline through Month 6 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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