Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)
NCT ID: NCT06272487
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
375 participants
INTERVENTIONAL
2024-02-29
2025-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zilebesiran
Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.
Zilebesiran
Zilebesiran administered by subcutaneous (SC) injection
Placebo
Participants will receive placebo on Day 1 of the 6-month DB treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.
Placebo
Placebo administered by SC injection
Interventions
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Zilebesiran
Zilebesiran administered by subcutaneous (SC) injection
Placebo
Placebo administered by SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mean seated office SBP ≥140 mmHg and ≤170 mmHg
* 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM
* Must be on stable therapy with 2 to 4 classes of antihypertensive medications
Exclusion Criteria
* Orthostatic hypotension
* Proteinuria \>3 g/day
* Serum potassium \>4.8 milliequivalents per liter (mEq/L)
18 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Alexander City, Alabama, United States
Clinical Trial Site
Daphne, Alabama, United States
Clinical Trial Site
Foley, Alabama, United States
Clinical Trial Site
Huntsville, Alabama, United States
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Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Covina, California, United States
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Encinitas, California, United States
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Garden Grove, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Northridge, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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Santa Ana, California, United States
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Simi Valley, California, United States
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Vacaville, California, United States
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Van Nuys, California, United States
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West Hills, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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Middlebury, Connecticut, United States
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Waterbury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Daytona Beach, Florida, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jensen Beach, Florida, United States
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Lake City, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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The Villages, Florida, United States
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Winter Haven, Florida, United States
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Acworth, Georgia, United States
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Atlanta, Georgia, United States
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Douglasville, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Thomasville, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Richmond, Indiana, United States
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El Dorado, Kansas, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Owensboro, Kentucky, United States
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Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Flint, Michigan, United States
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Roseville, Michigan, United States
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Ypsilanti, Michigan, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Columbus, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Portsmouth, New Hampshire, United States
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Berlin, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Monroe, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Marion, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Camp Hill, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Myrtle Beach, South Carolina, United States
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Rapid City, South Dakota, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Coppell, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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El Paso, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Shenandoah, Texas, United States
Clinical Trial Site
Sherman, Texas, United States
Clinical Trial Site
Splendora, Texas, United States
Clinical Trial Site
Stephenville, Texas, United States
Clinical Trial Site 1 - Tomball
Tomball, Texas, United States
Clinical Trial Site 2 - Tomball
Tomball, Texas, United States
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Burlington, Vermont, United States
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Burke, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Wauwatosa, Wisconsin, United States
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Bruce, Australian Capital Territory, Australia
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Sydney, Australian Capital Territory, Australia
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Brookvale, New South Wales, Australia
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Concord, New South Wales, Australia
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Kanwal, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Sherwood, Queensland, Australia
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Sippy Downs, Queensland, Australia
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Garran, , Australia
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Perth, , Australia
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Winnipeg, Manitoba, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Québec, , Canada
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Bayamón, , Puerto Rico
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Ponce, , Puerto Rico
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Basel, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Lucerne, , Switzerland
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Luton, Bedfordshire, United Kingdom
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Luton, Bedfordshire, United Kingdom
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Fowey, Cornwall, United Kingdom
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Liskeard, Cornwall, United Kingdom
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Newquay, Cornwall, United Kingdom
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Torpoint, Cornwall, United Kingdom
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Chesterfield, Derbyshire, United Kingdom
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Plymouth, Devon, United Kingdom
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Bristol, Gloucestershire, United Kingdom
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Canterbury, Kent, United Kingdom
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Bellshill, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Manchester, Lancashire, United Kingdom
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Leicester, Leicestershire, United Kingdom
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Hexham, Northumberland, United Kingdom
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Glasgow, Scotland, United Kingdom
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Carshalton, Surrey, United Kingdom
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Birmingham, , United Kingdom
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Cardriff, , United Kingdom
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Chorley, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Clinical Trial Site
Pickering, , United Kingdom
Countries
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Other Identifiers
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ALN-AGT01-007
Identifier Type: -
Identifier Source: org_study_id
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