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New treatment option for High Risk Cardiovascular Disease
Official title Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
ClinicalTrials.gov ID: NCT07181109
What this study is testing
What is Zilebesiran?
Zilebesiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for high risk cardiovascular disease.
Also referred to as ALN-AGT01.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Is 18 years or older for patients with established cardiovascular disease (CVD)
- Is 55 years or older for patients with high risk for CVD
- Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide...
You likely can't join if
- Has known history of secondary hypertension
- Has symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
- Has total serum bilirubin \>1.5×ULN
- Has international normalized ratio (INR) \>1.5
- Has serum potassium \>4.8 mEq/L
See the full eligibility criteria
- Is 18 years or older for patients with established cardiovascular disease (CVD)
- Is 55 years or older for patients with high risk for CVD
- Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
- Has known history of secondary hypertension
- Has symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
- Has total serum bilirubin \>1.5×ULN
- Has international normalized ratio (INR) \>1.5
- Has serum potassium \>4.8 mEq/L
- Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Foley, Alabama, United States
- Huntsville, Alabama, United States
- Sheffield, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Sun City West, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Yuma, Arizona, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Chula Vista, California, United States
- Covina, California, United States
- Escondido, California, United States
+ 706 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fairhope, Alabama, United States; Foley, Alabama, United States; Huntsville, Alabama, United States; Sheffield, Alabama, United States; Chandler, Arizona, United States and 720 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.