Hypertension Clinical Trial
— KARDIA-1Official title:
A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in Patients With Mild-to-Moderate Hypertension
| 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 ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.
| Status | Active, not recruiting |
| Enrollment | 394 |
| Est. completion date | December 4, 2024 |
| Est. primary completion date | April 4, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Daytime mean SBP =135 mmHg and =160 mmHg by ABPM, without antihypertensive medication Exclusion Criteria: - Secondary hypertension, orthostatic hypotension - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN) - Elevated potassium >5 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, newly diagnosed Type 2 diabetes mellitus - 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 | Chicoutimi | Quebec |
| Canada | Clinical Trial Site | London | Ontario |
| Canada | Clinical Trial Site | Mirabel | Quebec |
| Canada | Clinical Trial Site | Montréal | Quebec |
| Canada | Clinical Trial Site | New Minas | Nova Scotia |
| Canada | Clinical Trial Site | Quebec City | Quebec |
| Canada | Clinical Trial Site | Red Deer | Alberta |
| Canada | Clinical Trial Site | Toronto | Ontario |
| Canada | Clinical Trial Site | Trois-Rivières | Quebec |
| Canada | Clinical Trial Site | Victoriaville | Quebec |
| Puerto Rico | Clinical Trial Site | Bayamon | |
| Puerto Rico | Clinical Trial Site | Cidra | |
| Puerto Rico | Clinical Trial Site | Ponce | |
| Puerto Rico | Clinical Trial Site | San Juan | |
| Ukraine | Clinical Trial Site | Ivano-Frankivs'k | |
| Ukraine | Clinical Trial Site | Kharkiv | |
| Ukraine | Clinical Trial Site | Kharkiv | |
| Ukraine | Clinical Trial Site | Kharkiv | |
| Ukraine | Clinical Trial Site | Kharkiv | |
| Ukraine | Clinical Trial Site | Kyiv | |
| Ukraine | Clinical Trial Site | Kyiv | |
| Ukraine | Clinical Trial Site | Kyiv | |
| Ukraine | Clinical Trial Site | Kyiv | |
| Ukraine | Clinical Trial Site | Lviv | |
| Ukraine | Clinical Trial Site | Odesa | |
| Ukraine | Clinical Trial Site | Úzhgorod | |
| Ukraine | Clinical Trial Site | Vinnytsia | |
| United Kingdom | Clinical Trial Site | Chorley | |
| United Kingdom | Clinical Trial Site | Glasgow | |
| United Kingdom | Clinical Trial Site | Hexham | |
| United Kingdom | Clinical Trial Site | London | |
| United Kingdom | Clinical Trial Site | Manchester | |
| United States | Clinical Trial Site | Acworth | Georgia |
| United States | Clinical Trial Site | Appomattox | Virginia |
| United States | Clinical Trial Site | Baltimore | Maryland |
| United States | Clinical Trial Site | Berlin | New Jersey |
| United States | Clinical Trial Site | Beverly Hills | California |
| United States | Clinical Trial Site | Birmingham | Alabama |
| United States | Clinical Trial Site | Bronx | New York |
| United States | Clinical Trial Site | Burke | Virginia |
| United States | Clinical Trial Site | Carrollton | Texas |
| United States | Clinical Trial Site | Cedar Park | Texas |
| United States | Clinical Trial Site | Champaign | Illinois |
| United States | Clinical Trial Site | Clearwater | Florida |
| United States | Clinical Trial Site | Columbus | Georgia |
| United States | Clinical Trial Site | Coral Gables | Florida |
| United States | Clinical Trial Site | Dallas | Texas |
| United States | Clinical Trial Site | Fayetteville | Georgia |
| United States | Clinical Trial Site | Fleming Island | Florida |
| United States | Clinical Trial Site | Franklin | Indiana |
| United States | Clinical Trial Site | Greenfield | Indiana |
| United States | Clinical Trial Site | Greensboro | North Carolina |
| United States | Clinical Trial Site | Greensboro | North Carolina |
| United States | Clinical Trial Site | Greenville | South Carolina |
| United States | Clinical Trial Site | Henderson | Nevada |
| United States | Clinical Trial Site | Holladay | Utah |
| United States | Clinical Trial Site | Hollywood | Florida |
| United States | Clinical Trial Site | Hollywood | Florida |
| United States | Clinical Trial Site | Houston | Texas |
| United States | Clinical Trial Site | Houston | Texas |
| United States | Clinical Trial Site | Inverness | Florida |
| 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 | La Mesa | California |
| United States | Clinical Trial Site | Lake Charles | Louisiana |
| United States | Clinical Trial Site | Las Vegas | Nevada |
| United States | Clinical Trial Site | Los Angeles | California |
| United States | Clinical Trial Site | Macon | Georgia |
| United States | Clinical Trial Site | Magnolia | Texas |
| United States | Clinical Trial Site | Medford | Oregon |
| United States | Clinical Trial Site | Memphis | Tennessee |
| 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 | Naples | Florida |
| United States | Clinical Trial Site | New Orleans | Louisiana |
| United States | Clinical Trial Site | New York | New York |
| United States | Clinical Trial Site | Orlando | Florida |
| United States | Clinical Trial Site | Oxnard | California |
| United States | Clinical Trial Site | Pearland | Texas |
| United States | Clinical Trial Site | Prairieville | Louisiana |
| United States | Clinical Trial Site | Quincy | Illinois |
| United States | Clinical Trial Site | Rancho Cucamonga | California |
| United States | Clinical Trial Site | River Forest | Illinois |
| United States | Clinical Trial Site | Rock Hill | South Carolina |
| United States | Clinical Trial Site | S. Gate | California |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Diego | California |
| United States | Clinical Trial Site | San Francisco | California |
| United States | Clinical Trial Site | Savannah | Georgia |
| United States | Clinical Trial Site | Stephenville | Texas |
| United States | Clinical Trial Site | Tempe | Arizona |
| 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 | Tulsa | Oklahoma |
| United States | Clinical Trial Site | Valparaiso | Indiana |
| 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 Trial Site | West Des Moines | Iowa |
| United States | Clinical Trial Site | Woodland Hills | California |
| Lead Sponsor | Collaborator |
|---|---|
| Alnylam Pharmaceuticals |
United States, Canada, Puerto Rico, Ukraine, 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 | Change from Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM | Baseline through Month 6 | ||
| Secondary | Change from Baseline at Month 6 in Office SBP | Baseline through Month 6 | ||
| Secondary | Proportion of Patients with 24-hour Mean SBP Assessed by ABPM <130 mmHg and/or Reduction =20 mmHg without Additional Antihypertensive Medications at Month 6 | Baseline through Month 6 | ||
| Secondary | Time-adjusted Change from Baseline in 24-hour Mean SBP and Diastolic Blood Pressure (DBP), Assessed by ABPM | Baseline through Month 6 | ||
| Secondary | Change from Baseline in 24-hour mean DBP, Assessed by ABPM | Baseline through Month 6 | ||
| Secondary | Change from Baseline in Office SBP and DBP | Baseline through Month 6 | ||
| Secondary | Change in Serum Angiotensinogen (AGT) | Baseline through Month 6 | ||
| Secondary | Change from Baseline in Daytime and Nighttime SBP and DBP by ABPM (Including Dipping Pattern) | Baseline through Month 6 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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