A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension (KARDIA-1)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication
EXCLUSION CRITERIA
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hypertension
Age (in years)
18 - 75
Phase
Phase 2
Participants needed
394
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
Alnylam Pharmaceuticals
ClinicalTrials.gov identifier
NCT04936035
Study number
ALN-AGT01-002
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