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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04936035
Other study ID # ALN-AGT01-002
Secondary ID 2021-001248-82
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 7, 2021
Est. completion date December 4, 2024

Study information

Verified date May 2024
Source Alnylam Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Participants will receive ALN-AGT01 or placebo for the first 6 months of the 12-month double-blind (DB) treatment period. Participants randomized to placebo will be re-randomized at Month 6 to 1 of the 4 initial ALN-AGT01 regimens until the end of the 12-month DB treatment period. Participants randomized to ALN-AGT01 regimens will remain on their originally assigned regimens through remainder of the study.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo administered by SC injection
ALN-AGT01
ALN-AGT01 administered by SC injection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  Ukraine,  United Kingdom, 

Outcome

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
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