A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Last updated: June 3, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Emphysema

Bronchiectasis

Chronic Obstructive Lung Disease

Treatment

Placebo

AZD6793

Clinical Study ID

NCT07082738
D7860C00006
  • Ages > 40
  • All Genders

Study Summary

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥40 years of age at the time of signing the informed consent.

  • Documented primary diagnosis of 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-BDFEV1 ≥ 25% to < 80% of predicted normal at Visit 2.

  • Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 monthsprior to screening.

  • Documented stable regimen of inhaled triple maintenance therapy or inhaled dualmaintenance 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 4weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days)prior to Visit 3 (randomisation).

  • Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

Exclusion

Exclusion Criteria:

  • Clinically important pulmonary disease other than COPD (eg, asthma [currentdiagnosis per GINA or other accepted guidelines], active pulmonary infection,clinically significant bronchiectasis when bronchiectasis is the predominantdiagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associatedwith obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliarydyskinesia).

  • Radiological findings suggestive of a respiratory disease other than COPD that issignificantly contributing to the participant's respiratory symptoms.

  • Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic,renal, neurological, musculoskeletal, infectious, endocrine, metabolic,haematological, psychiatric disorder, major physical and/or cognitive impairment.

  • Significant left heart failure.

  • Unstable angina, acute coronary syndrome/acute myocardial infarction or coronaryintervention with percutaneous coronary intervention/coronary artery bypass graftwithin 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy,clinically significant aortic stenosis, or signs of pulmonary oedema or volumeoverload.

  • Pulmonary arterial hypertension, either idiopathic or due to connective tissue orthromboembolic disease.

  • History of another underlying condition that predisposes the participant toinfections.

  • History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed byeither a gastroenterologist or by histopathology.

  • Abnormal laboratory findings.

  • Participants with evidence of active liver disease and/or evidence of chronic liverdisease.

  • Participants with history of HIV infection or who test positive for HIV.

  • History of lung volume reduction surgery.

  • Current or history of malignancy within 5 years before the screening visit.

Study Design

Total Participants: 987
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 27, 2025
Estimated Completion Date:
November 05, 2027

Study Description

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 3-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)

Approximately 350 sites globally will participate in this study. Approximately 970 participants will be randomized to AZD6793 or Placebo. Following CSP V.3.0, participants will be randomized in a 1:1:1 ratio of two doses of AZD6793 vs Placebo.

Connect with a study center

  • Research Site

    Alberdi, X5033DCE
    Argentina

    Active - Recruiting

  • Research Site

    Buenos Aires 3435910, C1094AAD
    Argentina

    Site Not Available

  • Research Site

    CABA, C1426
    Argentina

    Active - Recruiting

  • Research Site

    Ciudad Autónoma de Bs As, C1182ACD
    Argentina

    Active - Recruiting

  • Research Site

    Ciudad de Buenos Aires, 1060
    Argentina

    Active - Recruiting

  • Research Site

    Mar del Plata, B7600GWV
    Argentina

    Active - Recruiting

  • Research Site

    Mar del Plata 3430863, B7600GWV
    Argentina

    Active - Recruiting

  • Research Site

    Mendoza, M5500CCG
    Argentina

    Active - Recruiting

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    Ranelagh, 1886
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Research Site

    Rosario 3838583, 2000
    Argentina

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  • Research Site

    San Miguel de Tucumán, 4000
    Argentina

    Active - Recruiting

  • Research Site

    Cairns, 4870
    Australia

    Completed

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    Nedlands, 6009
    Australia

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    Norwood, 5067
    Australia

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    Osborne Park, 6017
    Australia

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    South Brisbane, 4101
    Australia

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    Wollongong, 2500
    Australia

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    Dupnitsa, 2600
    Bulgaria

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    Haskovo, 6300
    Bulgaria

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    Plovdiv, 4003
    Bulgaria

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    Sofia, 1756
    Bulgaria

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    Stara Zagora, 6003
    Bulgaria

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    Veliko Tarnovo, 5000
    Bulgaria

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    Yambol, 8600
    Bulgaria

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    Edmonton, Alberta T6G 2G3
    Canada

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    Winnipeg, Manitoba R3L 1Z5
    Canada

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    Truro, Nova Scotia B2N 1L2
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    Ajax, Ontario L1S 2J5
    Canada

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    Burlington, Ontario L7N 3V2
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    Guelph, Ontario N1H 6J2
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    Hamilton, Ontario L8L 5G4
    Canada

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    Stoney Creek, Ontario L8G 2V6
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    Québec, Quebec G1V 4G5
    Canada

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    Trois-Rivières, Quebec G9A 4P3
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    Victoriaville, Quebec G6P 3Z8
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    Trois-Rivières 6169141, Quebec 6115047 G9A 4P3
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    Canada

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    Chile

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    Concepción, 4070280
    Chile

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    Santiago, 8380453
    Chile

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    Santiago 3871336, 7750495
    Chile

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    Talca, 3481349
    Chile

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    Temuco, 4810345
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    Viña del Mar, 2540488
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    Baotou, 014040
    China

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    Beijing, 100029
    China

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    Beijing 1816670, 101100
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    Changchun, 130021
    China

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    Changsha, 410015
    China

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    Changsha 1815577, 410015
    China

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    Chengdu, 610021
    China

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    Chengdu 1815286, 610041
    China

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    Chongqing, 400042
    China

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    Fuzhou, 350031
    China

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    Guangzhou, 510163
    China

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    Guangzhou 1809858, 510163
    China

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    Hangzhou, 310009
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    Hohhot, 010050
    China

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    Jinan, 250013
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    Kunming, 650032
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    Linhai, 317000
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    Nanchang, 330006
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    Nanjing, 210006
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    Nanning, 530021
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    Qingdao, 266011
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    Shanghai, 200433
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    Shanghai 1796236, 200025
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    Shenyang, 110004
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    Wuhan, 430030
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    Wuhan 1791247, 430030
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    Athens 264371, 11527
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    Ioannina, 45500
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    Thessaloniki, 57001
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    Thessaloniki 734077, 57001
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    Balassagyarmat, 2660
    Hungary

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    Budapest, 1044
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    Debrecen, 4032
    Hungary

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    Edelény, 3780
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    Encs, 3860
    Hungary

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    Gödöllő, 2100
    Hungary

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    Hajdúnánás, 4080
    Hungary

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    Nyíregyháza-Sóstóhegy, 4481
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    Pécs, 7635
    Hungary

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    Szombathely, 9700
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    Törökbálint, 2045
    Hungary

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    Belagavi, 590010
    India

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    Coimbatore, 641028
    India

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    Dehradun, 248001
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    Hyderabad 1269843, 500055
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    Mumbai, 400008
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    Nagpur, 440019
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    Vijayawada, 520 008
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    Busto Arsizio, 21052
    Italy

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    Cuneo, 12100
    Italy

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    Ferrara, 44100
    Italy

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    Milan, 20122
    Italy

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    Monza, 20900
    Italy

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    Naples, 80131
    Italy

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    Pavia, 27100
    Italy

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    Roma, 00161
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    Statte, 74010
    Italy

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    Telese Terme, 82037
    Italy

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    Chiba, 260-0852
    Japan

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    Fukuoka, 814-0180
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    Fukushima, 960-1295
    Japan

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    Ginowan-shi, 901-2214
    Japan

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    Hachioji-shi, 193-0998
    Japan

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    Hamamatsu, 431-3192
    Japan

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    Hiroshima, 734-8530
    Japan

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    Izumi-shi, 594-0073
    Japan

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    Kamakura, 247-8533
    Japan

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    Kanazawa, 920-8650
    Japan

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    Kasuga-shi, 816-0813
    Japan

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    Kawasaki-shi, 216-8511
    Japan

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    Kiyosu-shi, 452-0001
    Japan

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    Kochi, 780-8077
    Japan

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    Kumamoto, 861-8520
    Japan

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    Kyoto, 612-8555
    Japan

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    Kōtoku, 136-0075
    Japan

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    Maebashi, 371-8511
    Japan

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    Matsuyama, 790-8524
    Japan

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    Minoh, 562-0003
    Japan

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    Minokamo Shi, 505-8510
    Japan

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    Miura, 238-0111
    Japan

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    Mizunami-shi, 509-6134
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    Osaka, 545-8586
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    Sagamihara-shi, 252-0143
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    Sapporo, 063-0005
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    Sasebo-shi, 857-8511
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    Shimotsuga-gun, 321-0293
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    Shinjuku-ku, 160-0023
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    Tachikawa-shi, 190-8531
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    Toon-shi, 791-0281
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    Toyota, 471-0062
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    Ube, 755-8505
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    Yokkaichi-shi, 510-8561
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    Yokohama, 245-8575
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    Yokohama 1848354, 227-8501
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    Ōita, 870-0033
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    Daegu, 42415
    Korea, Republic of

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    Seoul, 143-729
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    Chihuahua City, 31210
    Mexico

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    Durango, 34000
    Mexico

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    Guadalajara, 44200
    Mexico

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    Guadalajara 4005539, 44200
    Mexico

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    Mexico City, 04100
    Mexico

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    Mexico City 3530597, 04100
    Mexico

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    Monterrey, 64060
    Mexico

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    Monterrey 3995465, 64465
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    Lima, 15024
    Peru

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    Lima 3936456, 15024
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    Bialystok, 15-044
    Poland

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    Bydgoszcz, 85-796
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    Chęciny, 26-060
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    Elblag, 82-300
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    Karczew, 05-480
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    Katowice 3096472, 40-081
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    Daegu, 42601
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    United Kingdom

    Active - Recruiting

  • Research Site

    Glasgow, G4 0SF
    United Kingdom

    Active - Recruiting

  • Research Site

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Research Site

    London, NW3 2QG
    United Kingdom

    Completed

  • Research Site

    London 2643743, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Research Site

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Active - Recruiting

  • Research Site

    Thetford, IP24 1JD
    United Kingdom

    Active - Recruiting

  • Research Site

    Wythenshawe, M23 9QZ
    United Kingdom

    Active - Recruiting

  • Research Site

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Research Site

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Research Site

    Phoenix, Arizona 85044
    United States

    Active - Recruiting

  • Research Site

    Phoenix 5308655, Arizona 5551752 85044
    United States

    Active - Recruiting

  • Research Site

    Canoga Park, California 91303
    United States

    Site Not Available

  • Research Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Research Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Research Site

    Norco, California 92860
    United States

    Active - Recruiting

  • Research Site

    Tustin, California 92780
    United States

    Active - Recruiting

  • Research Site

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Research Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Research Site

    Cape Coral, Florida 33990
    United States

    Active - Recruiting

  • Research Site

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Research Site

    Lake City, Florida 32055
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Research Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Research Site

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Research Site

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • Research Site

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Research Site

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Research Site

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Research Site

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Research Site

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Research Site

    Clearwater 4151316, Florida 4155751 33756
    United States

    Active - Recruiting

  • Research Site

    Miami 4164138, Florida 4155751 33125
    United States

    Active - Recruiting

  • Research Site

    Tampa 4174757, Florida 4155751 33607
    United States

    Active - Recruiting

  • Research Site

    Suwanee, Georgia 30024
    United States

    Active - Recruiting

  • Research Site

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40503
    United States

    Terminated

  • Research Site

    Zachary, Louisiana 70791
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Research Site

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

  • Research Site

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

  • Research Site

    Farmington Hills, Michigan 48336
    United States

    Active - Recruiting

  • Research Site

    Garden City, Michigan 48135
    United States

    Active - Recruiting

  • Research Site

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Research Site

    Chesterfield, Missouri 63005
    United States

    Active - Recruiting

  • Research Site

    Hannibal, Missouri 63401
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Research Site

    Kalispell, Montana 59901
    United States

    Active - Recruiting

  • Research Site

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Research Site

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Research Site

    Marion, Ohio 43302
    United States

    Active - Recruiting

  • Research Site

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Research Site

    Tulsa, Oklahoma 74133
    United States

    Active - Recruiting

  • Research Site

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97202
    United States

    Active - Recruiting

  • Research Site

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Research Site

    DuBois, Pennsylvania 15801
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Research Site

    Scottdale, Pennsylvania 15683
    United States

    Active - Recruiting

  • Research Site

    Smithfield, Pennsylvania 15478
    United States

    Active - Recruiting

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Active - Recruiting

  • Research Site

    Lancaster, South Carolina 29720
    United States

    Active - Recruiting

  • Research Site

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Research Site

    Rapid City, South Dakota 57702
    United States

    Active - Recruiting

  • Research Site

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Research Site

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • Research Site

    Johnson City, Tennessee 37604
    United States

    Active - Recruiting

  • Research Site

    Boerne, Texas 78006
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75254
    United States

    Active - Recruiting

  • Research Site

    Denison, Texas 75020
    United States

    Active - Recruiting

  • Research Site

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Terminated

  • Research Site

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Research Site

    Lewisville, Texas 75067
    United States

    Active - Recruiting

  • Research Site

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Research Site

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • Research Site

    Pearland, Texas 77584
    United States

    Suspended

  • Research Site

    Houston 4699066, Texas 4736286 77002
    United States

    Active - Recruiting

  • Research Site

    Colchester, Vermont 05446
    United States

    Active - Recruiting

  • Research Site

    Norfolk, Virginia 23504
    United States

    Active - Recruiting

  • Research Site

    Williamsburg, Virginia 23188
    United States

    Active - Recruiting

  • Research Site

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

  • Research Site

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

  • Research Site

    Da Nang, 55000
    Vietnam

    Active - Recruiting

  • Research Site

    Dong Thập, 83000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 10000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Huế, 530000
    Vietnam

    Active - Recruiting

  • Research Site

    Hà Nội, 100000
    Vietnam

    Site Not Available

  • Research Site

    Rach Gia, 920000
    Vietnam

    Suspended

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