A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
NCT ID: NCT06883305
Last Updated: 2025-11-10
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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RECRUITING
PHASE3
990 participants
INTERVENTIONAL
2025-03-18
2029-06-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose 1 of Tezepelumab
Tezepelumab, SC, Q4W
Tezepelumab
Tezepelumab subcutaneous injection
Dose 2 of Tezepelumab
Tezepelumab, SC, Q4W
Tezepelumab
Tezepelumab subcutaneous injection
Matching Placebo
Matching placebo, SC, Q4W
Placebo
Placebo subcutaneous injection
Interventions
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Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. COPD diagnosis ≥1 year,
3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
6. EOS ≥ 150 cells/μL during screening
7. CAT ≥15 at screening
8. Former or current smokers ≥10 pack-years
Exclusion Criteria
2. Asthma, incl. pediatric, or ACOS
3. Any unstable disorder that can impact participants safety or study outcomes
4. Tuberculosis requiring treatment within 12 months prior V2
5. Malignancies current or past
Concomitant therapies:
* Macrolides (less than 6 months)
* Systemic immuno-suppressive, -modulating medications
6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
40 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dave Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
Locations
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Research Site
Foley, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Garden Grove, California, United States
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Newport Beach, California, United States
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Torrance, California, United States
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Clearwater, Florida, United States
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Cutler Bay, Florida, United States
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Cutler Bay, Florida, United States
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DeBary, Florida, United States
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Gainesville, Florida, United States
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Homestead, 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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Orlando, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Lithonia, Georgia, United States
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Rincon, Georgia, United States
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Chicago, Illinois, United States
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Palos Hills, Illinois, United States
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Winfield, Illinois, United States
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Munster, Indiana, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Saint Cloud, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Papillion, Nebraska, United States
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Las Vegas, Nevada, United States
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Sewell, New Jersey, United States
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Toms River, New Jersey, United States
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Buffalo, New York, United States
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Buffalo, New York, United States
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Cortland, New York, United States
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Horseheads, New York, United States
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High Point, North Carolina, United States
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Kings Mountain, North Carolina, United States
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New Bern, 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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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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DuBois, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Franklin, Tennessee, United States
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Johnson City, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Kerrville, Texas, United States
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Mansfield, Texas, United States
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Clearfield, Utah, United States
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Morgantown, West Virginia, United States
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Cudahy, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Bragança Paulista, , Brazil
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Brasília, , Brazil
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Campinas, , Brazil
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Chapecó, , Brazil
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Curitiba, , Brazil
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Jaú, , Brazil
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Mossoró, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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Vitória, , Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Winchester, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Laurent, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Concepción, , Chile
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Curicó, , Chile
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Quillota, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Anyang, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Hefei, , China
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Hengyang, , China
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Heze, , China
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Hohhot, , China
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Huizhou, , China
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Jinan, , China
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Jinan, , China
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Jinhua, , China
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Linhai, , China
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Loudi, , China
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Nanchang, , China
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Nanchong, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Nanning, , China
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Pingxiang, , China
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Qingdao, , China
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Qingyuan, , China
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Sanya, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shantou, , China
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Shenyang, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Suining Shi, , China
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Taiyuan, , China
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Taiyuan, , China
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Taizhou, , China
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Tianjin, , China
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Wenzhou, , China
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Wuhan, , China
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Wuhan, , China
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Xinxiang, , China
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Xuzhou, , China
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Xuzhou, , China
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Yangzhou, , China
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Yichang, , China
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Yinchuan, , China
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Yinchuan, , China
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Zhangzhou, , China
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Brandýs nad Labem, , Czechia
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Brno, , Czechia
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Jindřichův Hradec, , Czechia
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Lovosice, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Varnsdorf, , Czechia
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København NV, , Denmark
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Bendorf, , Germany
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Berlin, , Germany
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Haltern am See, , Germany
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Hanover, , Germany
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Immenhausen, , Germany
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Lübeck, , Germany
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Marburg, , Germany
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Rosenheim, , Germany
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Stuttgart, , Germany
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Wiesbaden, , Germany
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Ahmedabad, , India
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Ahmedabad, , India
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Belagavi, , India
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Coimbatore, , India
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Dehradun, , India
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Delhi, , India
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Faridabad, , India
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Gurgaon, , India
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Kochi, , India
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Kolkata, , India
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Lucknow, , India
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Madurai, , India
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Mysuru, , India
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Nagpur, , India
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Pune, , India
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Vadodara, , India
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Florence, , Italy
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Milan, , Italy
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Montebelluna, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Roma, , Italy
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Sassari, , Italy
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Telese Terme, , Italy
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Tradate, , Italy
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Alor Star, , Malaysia
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Kajang, , Malaysia
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Terengganu, , Malaysia
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Kuantan, , Malaysia
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Kuching, , Malaysia
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Benito Juárez, , Mexico
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Chihuahua City, , Mexico
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Cuauhtémoc, , Mexico
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Oaxaca City, , Mexico
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San Juan del Río, , Mexico
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Tijuna, , Mexico
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Veracruz, , Mexico
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Zapopan, , Mexico
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Zapopan, , Mexico
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Iloilo City, , Philippines
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Las Piñas, , Philippines
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Manadaluyong City, , Philippines
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Manila, , Philippines
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Marilao, , Philippines
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Quezon City, , Philippines
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Tondo, , Philippines
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Chrzanów, , Poland
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Grodzisk Mazowiecki, , Poland
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Karczew, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Ostróda, , Poland
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Piaseczno, , Poland
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Poznan, , Poland
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Płock, , Poland
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Humenné, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Martin, , Slovakia
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Trnava, , Slovakia
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Anyang-si, , South Korea
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Daegu, , South Korea
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Iksan-si, , South Korea
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Jeonju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Uijeongbu-si, , South Korea
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Wŏnju, , South Korea
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Barakaldo, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Valencia, , Spain
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Bradford, , United Kingdom
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Brighton, , United Kingdom
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Cottingham, , United Kingdom
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Glasgow, , United Kingdom
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Halifax, , United Kingdom
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Leeds, , United Kingdom
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Portsmouth, , United Kingdom
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Tyne and Wear, , United Kingdom
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Wakefield, , United Kingdom
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D5241C00006
Identifier Type: -
Identifier Source: org_study_id