Dysautonomia International

Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Purpose

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.

Conditions

High Risk Cardiovascular Disease
Hypertension
High Cardiovascular Risk

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion 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

Exclusion Criteria

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Zilebesiran 300 mg	Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.	Drug: Zilebesiran Zilebesiran will be administered SC Other names: ALN-AGT01
Placebo Comparator Placebo	Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.	Drug: Placebo Placebo will be administered SC

Recruiting Locations

Clinical Trial Site
Birmingham, Alabama 35211

Clinical Trial Site
Fairhope, Alabama 36532

Clinical Trial Site
Foley, Alabama 36535

Clinical Trial Site
Huntsville, Alabama 35805

Clinical Trial Site
Sheffield, Alabama 35660

Clinical Trial Site
Chandler, Arizona 85224

Clinical Trial Site
Gilbert, Arizona 85296

Clinical Trial Site
Phoenix, Arizona 85015

Clinical Trial Site
Phoenix, Arizona 85020

Clinical Trial Site
Sun City West, Arizona 85375

Clinical Trial Site
Tucson, Arizona 85741

Clinical Trial Site
Yuma, Arizona 85364

Clinical Trial Site
Little Rock, Arkansas 72204

Clinical Trial Site
Little Rock, Arkansas 72205

Clinical Trial Site
Beverly Hills, California 90211

Clinical Trial Site
Chula Vista, California 91910

Clinical Trial Site
Covina, California 91723

Clinical Trial Site
Escondido, California 92025

Clinical Trial Site
Glendale, California 91206

Clinical Trial Site
Lancaster, California 93534

Clinical Trial Site
Long Beach, California 90815

Clinical Trial Site
Lynwood, California 90262

Clinical Trial Site
Newhall, California 91321

Clinical Trial Site
Northridge, California 91325

Clinical Trial Site
Pasadena, California 91105

Clinical Trial Site
San Diego, California 92111

Clinical Trial Site
San Dimas, California 91773

Clinical Trial Site
Tarzana, California 91356

Clinical Trial Site
Toluca Lake, California 91602

Clinical Trial Site
Tustin, California 92780

Clinical Trial Site
Vista, California 92081

Clinical Trial Site
Walnut Creek, California 94598

Clinical Trial Site
Bridgeport, Connecticut 06610

Clinical Trial Site
Boca Raton, Florida 33434

Clinical Trial Site
Brandon, Florida 33511

Clinical Trial Site
Fleming Island, Florida 32003

Clinical Trial Site
Hialeah, Florida 33012

Clinical Trial Site
Hollywood, Florida 33024

Clinical Trial Site
Jacksonville, Florida 32205

Clinical Trial Site
Jacksonville, Florida 32216

Clinical Trial Site
Jensen Beach, Florida 34957

Clinical Trial Site
Leesburg, Florida 34748

Clinical Trial Site
Melbourne, Florida 32934

Clinical Trial Site
Miami, Florida 33134

Clinical Trial Site
Miami, Florida 33135

Clinical Trial Site
Miami, Florida 33155

Clinical Trial Site
Miami, Florida 33186

Clinical Trial Site
Orlando, Florida 32825

Clinical Trial Site
Palm Springs, Florida 33406

Clinical Trial Site
Tampa, Florida 33615

Clinical Trial Site
Wellington, Florida 33449

Clinical Trial Site
Atlanta, Georgia 30342

Clinical Trial Site
Brunswick, Georgia 31520

Clinical Trial Site
Columbus, Georgia 31904

Clinical Trial Site
Conyers, Georgia 30012

Clinical Trial Site
Conyers, Georgia 30094

Clinical Trial Site
Fayetteville, Georgia 30214

Clinical Trial Site
Johns Creek, Georgia 30024

Clinical Trial Site
Lawrenceville, Georgia 30044

Clinical Trial Site
Macon, Georgia 31201

Clinical Trial Site
Hazel Crest, Illinois 60429

Clinical Trial Site
Oak Brook, Illinois 60523

Clinical Trial Site
Orland Park, Illinois 60462

Clinical Trial Site
Tinley Park, Illinois 60477

Clinical Trial Site
Avon, Indiana 46123

Clinical Trial Site
Evansville, Indiana 47714

Clinical Trial Site
Greenfield, Indiana 46140

Clinical Trial Site
South Bend, Indiana 46617

Clinical Trial Site
Valparaiso, Indiana 46383

Clinical Trial Site
Hutchinson, Kansas 67502

Clinical Trial Site
Topeka, Kansas 66606

Clinical Trial Site
Wichita, Kansas 67214

Clinical Trial Site
Bowling Green, Kentucky 42101

Clinical Trial Site
Lexington, Kentucky 40503

Clinical Trial Site
Versailles, Kentucky 40383

Clinical Trial Site
Hammond, Louisiana 70403

Clinical Trial Site
Lafayette, Louisiana 70503

Clinical Trial Site
Opelousas, Louisiana 70570

Clinical Trial Site
Shreveport, Louisiana 71105

Clinical Trial Site
Zachary, Louisiana 70791

Clinical Trial Site
Baltimore, Maryland 21229

Clinical Trial Site
Beltsville, Maryland 20705

Clinical Trial Site
Bowie, Maryland 20715

Clinical Trial Site
Lanham, Maryland 20706

Clinical Trial Site
Rockville, Maryland 20850

Clinical Trial Site
Flint, Michigan 48504

Clinical Trial Site
Shelby, Michigan 48315

Clinical Trial Site
Southfield, Michigan 48075

Clinical Trial Site
Troy, Michigan 48085

Clinical Trial Site
Richfield, Minnesota 55423

Clinical Trial Site
Jackson, Mississippi 39216

Clinical Trial Site
Olive Branch, Mississippi 38654

Clinical Trial Site
Port Gibson, Mississippi 39150

Clinical Trial Site
Kansas City, Missouri 64111

Clinical Trial Site
Kansas City, Missouri 64151

Clinical Trial Site
St Louis, Missouri 63136

Clinical Trial Site
Fremont, Nebraska 68025

Clinical Trial Site
Bridgewater, New Jersey 08807

Clinical Trial Site
Albuquerque, New Mexico 87106

Clinical Trial Site
New Windsor, New York 12553

Clinical Trial Site
Rosedale, New York 11422

Clinical Trial Site
The Bronx, New York 10461

Clinical Trial Site
West Seneca, New York 14224

Clinical Trial Site
Westfield, New York 14787

Clinical Trial Site
Durham, North Carolina 27704

Clinical Trial Site
Greenville, North Carolina 27834

Clinical Trial Site
High Point, North Carolina 27260

Clinical Trial Site
Fargo, North Dakota 58104

Clinical Trial Site
Beavercreek, Ohio 45431

Clinical Trial Site
Cincinnati, Ohio 45212

Clinical Trial Site
Cincinnati, Ohio 45219

Clinical Trial Site
Columbus, Ohio 43213

Clinical Trial Site
Dayton, Ohio 45409

Clinical Trial Site
Lima, Ohio 45801

Clinical Trial Site
Maumee, Ohio 43537

Clinical Trial Site
Moore, Oklahoma 73160

Clinical Trial Site
Norman, Oklahoma 73069

Clinical Trial Site
Camp Hill, Pennsylvania 17701

Clinical Trial Site
Horsham, Pennsylvania 19044

Clinical Trial Site
Media, Pennsylvania 19063

Clinical Trial Site
Uniontown, Pennsylvania 15401

Clinical Trial Site
Columbia, South Carolina 29205

Clinical Trial Site
Greenville, South Carolina 29607

Clinical Trial Site
Greer, South Carolina 29650

Clinical Trial Site
Chattanooga, Tennessee 37412

Clinical Trial Site
Knoxville, Tennessee 37909

Clinical Trial Site
Knoxville, Tennessee 37923

Clinical Trial Site
Allen, Texas 75013

Clinical Trial Site
Amarillo, Texas 79106

Clinical Trial Site
Arlington, Texas 76012

Clinical Trial Site
Austin, Texas 78735

Clinical Trial Site
Austin, Texas 78759

Clinical Trial Site
Beaumont, Texas 77702

Clinical Trial Site
Carrollton, Texas 75006

Clinical Trial Site
Duncanville, Texas 75137

Clinical Trial Site
Houston, Texas 77002

Clinical Trial Site
Houston, Texas 77024

Clinical Trial Site
Houston, Texas 77025

Clinical Trial Site
Houston, Texas 77036

Clinical Trial Site
Houston, Texas 77043

Clinical Trial Site
Houston, Texas 77061

Clinical Trial Site
Houston, Texas 77070

Clinical Trial Site
Houston, Texas 77095

Clinical Trial Site
Humble, Texas 77338

Clinical Trial Site
Katy, Texas 77450

Clinical Trial Site
Laredo, Texas 78041

Clinical Trial Site
McAllen, Texas 78503

Clinical Trial Site
McKinney, Texas 75071

Clinical Trial Site
Mesquite, Texas 75149

Clinical Trial Site
Missouri City, Texas 77459

Clinical Trial Site
Paris, Texas 75462

Clinical Trial Site
Plano, Texas 75024

Clinical Trial Site
Port Arthur, Texas 77642

Clinical Trial Site
San Antonio, Texas 78220

Clinical Trial Site
San Antonio, Texas 78229

Clinical Trial Site
San Antonio, Texas 78231

Clinical Trial Site
San Antonio, Texas 78258

Clinical Trial Site
Sherman, Texas 75092

Clinical Trial Site
Sugar Land, Texas 77479

Clinical Trial Site
Waco, Texas 76712

Clinical Trial Site
Bountiful, Utah 84010

Clinical Trial Site
Bountiful, Utah 84025

Clinical Trial Site
Layton, Utah 84041

Clinical Trial Site
Arlington, Virginia 22205

Clinical Trial Site
Danville, Virginia 24541

Clinical Trial Site
Newport News, Virginia 23606

Clinical Trial Site
Norfolk, Virginia 23502

Clinical Trial Site
Richmond, Virginia 23219

Clinical Trial Site
Suffolk, Virginia 23435

Clinical Trial Site
Winchester, Virginia 22601

Clinical Trial Site
Bellevue, Washington 98007

More Details

Status: Recruiting
Sponsor: Alnylam Pharmaceuticals

Study Contact

Clinical Trial Information Line
1-877-ALNYLAM
clinicaltrials@alnylam.com