A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)
Status: Recruiting
Location: See all (335) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Participant must be ≥40 years of age at the time of signing the informed consent.
• Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
• Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of predicted normal at Visit 2.
• Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
• Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
• CAT score ≥ 10 at Visit 1.
• Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
• Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
• Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
Locations
United States
Alabama
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Birmingham
Arizona
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Glendale
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Phoenix
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Phoenix
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Phoenix
California
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Canoga Park
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La Mesa
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Los Angeles
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Newport Beach
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Norco
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Tustin
Colorado
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Lakewood
Florida
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Brandon
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Cape Coral
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Clearwater
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Clearwater
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Jacksonville
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Lake City
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami Lakes
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Naples
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Ocala
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Ormond Beach
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Plantation
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Sarasota
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Tamarac
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Tampa
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Tampa
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Winter Park
Georgia
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Suwanee
Iowa
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West Des Moines
Kentucky
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Lexington
Louisiana
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Zachary
Massachusetts
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Burlington
Maryland
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Baltimore
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Baltimore
Michigan
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Farmington Hills
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Garden City
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Grand Rapids
Missouri
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Chesterfield
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Hannibal
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St Louis
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St Louis
Montana
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Kalispell
North Carolina
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New Bern
New York
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Mount Kisco
Ohio
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Cleveland
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Marion
Oklahoma
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Oklahoma City
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Tulsa
Oregon
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Medford
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Portland
Pennsylvania
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Camp Hill
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Dubois
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Philadelphia
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Philadelphia
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Pittsburgh
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Scottdale
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Smithfield
South Carolina
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Lancaster
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Spartanburg
South Dakota
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Rapid City
Tennessee
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Chattanooga
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Franklin
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Johnson City
Texas
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Boerne
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Dallas
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Denison
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El Paso
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Houston
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Houston
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Houston
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Kingwood
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Lewisville
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Mansfield
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Mckinney
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Pearland
Virginia
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Norfolk
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Williamsburg
Vermont
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Colchester
Wisconsin
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Madison
West Virginia
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Morgantown
Other Locations
Argentina
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Alberdi
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Buenos Aires
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Buenos Aires
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Caba
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Capital Federal
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Mar Del Plata
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Mar Del Plata
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Mendoza
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Ranelagh
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Rosario
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San Miguel De Tucumán
Australia
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Cairns
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Norwood
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Osborne Park
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South Brisbane
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Wollongong
Bulgaria
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Dupnitsa
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Haskovo
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Plovdiv
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Sofia
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Stara Zagora
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Veliko Tarnovo
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Yambol
Canada
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Ajax
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Burlington
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Edmonton
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Guelph
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Hamilton
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Québec
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Saint-charles-borromée
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Saskatoon
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Sherbrooke
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Stoney Creek
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Trois-rivières
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Trois-rivières
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Truro
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Victoriaville
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Winnipeg
Chile
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Chile
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Concepción
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Santiago
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Santiago
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Santiago
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Talca
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Temuco
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Viña Del Mar
China
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Baotou
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Beijing
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Beijing
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Beijing
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Changchun
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Changsha
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Changsha
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Chengdu
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Chengdu
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Chengdu
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Chongqing
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Fuzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Hohhot
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Kunming
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Linhai
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Nanchang
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Nanjing
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Nanning
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Shanghai
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Shanghai
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Shenyang
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Wuhan
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Wuhan
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Xuzhou
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Zhengzhou
Denmark
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Aalborg
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Aarhus
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Esbjerg
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Hvidovre
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Odense C
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Roskilde
Germany
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Ahrensburg
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Bendorf
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Darmstadt
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Halle
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Hanover
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Landsberg
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Leipzig
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Lübeck
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Marburg
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Obertshausen
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Rosenheim
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Schleswig
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Wiesbaden
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Witten
Greece
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Athens
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Athens
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Athens
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Ioannina
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Thessaloniki
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Thessaloniki
Hungary
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Budapest
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Debrecen
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Edelény
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Encs
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Gödöllő
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Hajdúnánás
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Nyíregyháza-sóstóhegy
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Törökbálint
India
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Belagavi
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Coimbatore
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Dehradun
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Dwārka
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Hyderabad
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Hyderabad
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Kochi
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Mumbai
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Nagpur
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Vijayawada
Italy
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Busto Arsizio
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Cuneo
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Milan
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Monza
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Napoli
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Pavia
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Roma
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Statte
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Telese Terme
Japan
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Fukuoka
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Fukushima
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Ginowan-shi
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Hachioji-shi
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Hamamatsu
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Izumi-shi
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Kamakura
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Kochi
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Kumamoto
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Kyoto
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NOT_YET_RECRUITING
Minokamo Shi
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Ōita
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Sagamihara-shi
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Sapporo
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Shinjuku-ku
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Tachikawa-shi
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Toon-shi
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Ube
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Yokohama
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Yokohama
Mexico
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Chihuahua City
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Durango
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Guadalajara
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Guadalajara
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Mexico City
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Mexico City
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Monterrey
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Monterrey
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Monterrey
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Monterrey
Peru
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Lima
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Lima
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Lima
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Lima
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WITHDRAWN
Lima
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Lima
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Lima
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Lima
Poland
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Bialystok
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Bydgoszcz
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Chęciny
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Elblag
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Karczew
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Katowice
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Katowice
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Komorniki
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Ksawerów
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Lodz
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Ostróda
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Piaseczno
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Płock
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Poznan
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Rzeszów
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Szczecin
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Warsaw
Republic of Korea
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Anyang-si
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Cheongju-si
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Chuncheon
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Daegu
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Daegu
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Jeonju
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Seongnam-si
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Seoul
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NOT_YET_RECRUITING
Seoul
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RECRUITING
Seoul
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NOT_YET_RECRUITING
Seoul
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Seoul
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RECRUITING
Seoul
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Wŏnju
Spain
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Benalmádena
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Granollers
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Madrid
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Málaga
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Mérida
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Pozuelo De Alarcón
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Santander
Taiwan
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Changhua
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Kaohsiung City
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Taichung
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Taichung
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Taichung
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Taipei
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Taipei
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Taoyuan District
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RECRUITING
Yung Kang City
Turkey
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Adana
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Ankara
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Bursa
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İzmit
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Kayseri
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Mersin
Ukraine
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NOT_YET_RECRUITING
Chernivtsi
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RECRUITING
Ivano-frankivsk
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RECRUITING
Ivano-frankivsk
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NOT_YET_RECRUITING
Ivano-frankivsk
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NOT_YET_RECRUITING
Kyiv
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NOT_YET_RECRUITING
Kyiv
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RECRUITING
Kyiv
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NOT_YET_RECRUITING
Kyiv
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RECRUITING
Lutsk
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NOT_YET_RECRUITING
Ternopil
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RECRUITING
Uzhhorod
United Kingdom
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RECRUITING
Bradford
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NOT_YET_RECRUITING
Cottingham
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NOT_YET_RECRUITING
Glasgow
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NOT_YET_RECRUITING
Harrow
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RECRUITING
London
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NOT_YET_RECRUITING
London
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NOT_YET_RECRUITING
Newcastle Upon Tyne
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RECRUITING
Thetford
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NOT_YET_RECRUITING
Wythenshawe
Viet Nam
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NOT_YET_RECRUITING
Da Nang
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NOT_YET_RECRUITING
Hanoi
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Hanoi
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Ho Chi Minh City
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NOT_YET_RECRUITING
Huế
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2025-06-27
Estimated Completion Date:2027-11-05
Participants
Target number of participants:1160
Treatments
Experimental: Dose 1 of AZD6793
Approximately 290 participants will be randomized to receive Dose 1 of AZD6793
Experimental: Dose 2 of AZD6793
Approximately 290 participants will be randomized to receive Dose 2 of AZD6793
Experimental: Dose 3 of AZD6793
Approximately 290 participants will be randomized to receive Dose 3 of AZD6793
Placebo_comparator: Matching Placebo
Approximately 290 participants will be randomized to receive Matching Placebo