A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
NCT ID: NCT07011732
Last Updated: 2025-11-13
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
352 participants
INTERVENTIONAL
2025-07-10
2028-12-08
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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KarXT + KarX-EC
Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
ii) If no historical evidence available:.
A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:.
* Amyloid PET.
* Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
* Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
* Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:.
i) Attend all visits and report on participant's status.
ii) Oversee participant compliance with medication and study procedures.
iii) Participate in the study assessments and provide informed consent to participate in the study.
* History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
* AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
* CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
* At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):.
i) 1 or more aggressive behaviors occurring several times per week.
ii) 2 or more aggressive behaviors occurring once or twice per week.
iii) 3 or more aggressive behaviors occurring less than once per week.
Exclusion Criteria
i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
\- Prior/Concomitant Therapy.
i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
B. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
55 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Imaging Endpoints
Scottsdale, Arizona, United States
Advanced Research Center (ARC) - Anaheim
Anaheim, California, United States
Kaizen Brain Center
La Jolla, California, United States
Local Institution - 1662
Pomona, California, United States
Torrance Clinical Research
Torrance, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Local Institution - 1630
Colorado Springs, Colorado, United States
Local Institution - 1622
Maitland, Florida, United States
Local Institution - 1631
Maitland, Florida, United States
Local Institution - 1602
Miami, Florida, United States
Local Institution - 1618
Miami, Florida, United States
Hope Research Network - Miami
Miami, Florida, United States
Nuovida Research Center
Miami, Florida, United States
Local Institution - 1608
Ocala, Florida, United States
Combined Research Orlando (CRO)
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Local Institution - 1661
Savannah, Georgia, United States
Local Institution - 1655
Marrero, Louisiana, United States
CBH Health
Gaithersburg, Maryland, United States
Local Institution - 1663
Foxborough, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Mayflower Clinical Research
South Dartmouth, Massachusetts, United States
Local Institution - 1660
Springfield, Massachusetts, United States
Local Institution - 1665
Bloomfield Hills, Michigan, United States
Oakland Medical Research
Troy, Michigan, United States
Redbird Research
Las Vegas, Nevada, United States
Patient First MD
Middletown, New Jersey, United States
Local Institution - 1664
Princeton, New Jersey, United States
Local Institution - 1610
Inwood, New York, United States
Local Institution - 1656
New Windsor, New York, United States
Local Institution - 1645
Woodmere, New York, United States
Local Institution - 1658
Woodmere, New York, United States
Local Institution - 1601
Monroe, North Carolina, United States
Local Institution - 1659
Centerville, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
Local Institution - 1652
Columbia, South Carolina, United States
Local Institution - 1653
Columbia, South Carolina, United States
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas, United States
Local Institution - 1641
Salt Lake City, Utah, United States
Local Institution - 1646
Bennington, Vermont, United States
Local Institution - 1644
Seattle, Washington, United States
Local Institution - 1654
Spokane, Washington, United States
Local Institution - 1001
La Plata, Buenos Aires, Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina
Local Institution - 1006
Rosario, Santa Fe Province, Argentina
Local Institution - 1003
Buenos Aires, , Argentina
Local Institution - 1004
Córdoba, , Argentina
Local Institution - 1005
Córdoba, , Argentina
Local Institution - 1000
Córdoba, , Argentina
Local Institution - 1051
Brasília, Federal District, Brazil
Local Institution - 1052
Curitiba, Paraná, Brazil
Local Institution - 1053
Curitiba, Paraná, Brazil
Local Institution - 1058
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1054
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1057
Campinas, São Paulo, Brazil
Local Institution - 1056
São Paulo, São Paulo, Brazil
Local Institution - 1050
Rio de Janeiro, , Brazil
Local Institution - 1055
São Paulo, , Brazil
Local Institution - 1100
Sofia, Sofia-Grad, Bulgaria
Local Institution - 1101
Pleven, , Bulgaria
Local Institution - 1103
Razgrad, , Bulgaria
Local Institution - 1102
Varna, , Bulgaria
Local Institution - 1153
Hamilton, Ontario, Canada
Local Institution - 1155
London, Ontario, Canada
Local Institution - 1755
London, Ontario, Canada
Local Institution - 1151
Toronto, Ontario, Canada
Local Institution - 1154
Toronto, Ontario, Canada
Local Institution - 1152
Whitby, Ontario, Canada
Local Institution - 1150
Montreal, Quebec, Canada
Local Institution - 1805
Beijing, Beijing Municipality, China
Local Institution - 1810
Beijing, Beijing Municipality, China
Local Institution - 1815
Haidian District, Beijing Municipality, China
Local Institution - 1809
Guangzhou, Guangdong, China
Local Institution - 1802
Guangzhou, Guangdong, China
Local Institution - 1803
Changsha, Hunan, China
Local Institution - 1801
Nanjing, Jiangsu, China
Local Institution - 1800
Shanghai, Shanghai Municipality, China
Local Institution - 1816
Xian, Shanxi, China
Local Institution - 1814
Tianjin, Tianjin Municipality, China
Local Institution - 1804
Hangzhou, Zhejiang, China
Local Institution - 1812
Kunming, , China
Local Institution - 1550
Zagreb, City of Zagreb, Croatia
Local Institution - 1553
Zagreb, City of Zagreb, Croatia
Local Institution - 1554
Rijeka, , Croatia
Local Institution - 1551
Split, , Croatia
Local Institution - 1552
Varaždin, , Croatia
Local Institution - 1200
Pátrai, Achaḯa, Greece
Local Institution - 1205
Athens, Attica, Greece
Local Institution - 1202
Athens, Attica, Greece
Local Institution - 1206
Athens, , Greece
Local Institution - 1203
Athens, , Greece
Local Institution - 1207
Athens, , Greece
Local Institution - 1201
Ioannina, , Greece
Local Institution - 1204
Thessaloniki, , Greece
Local Institution - 1251
Hyderabad, Andhra Pradesh, India
Local Institution - 1255
Ahmedabad, Gujarat, India
Local Institution - 1252
Hyderabad, Telangana, India
Local Institution - 1254
Varanasi, Uttar Pradesh, India
Local Institution - 1250
Kolkata, West Bengal, India
Local Institution - 1256
Delhi, , India
Local Institution - 1253
New Delhi, , India
Local Institution - 1301
Hadano, Kanagawa, Japan
Local Institution - 1307
Kawasaki, Kanagawa, Japan
Local Institution - 1304
Sakai, Osaka, Japan
Local Institution - 1303
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan
Local Institution - 1300
Karatsu-shi, Saga-ken, Japan
Local Institution - 1305
Bunkyo-ku, Tokyo, Japan
Local Institution - 1302
Fukuoka, , Japan
Local Institution - 1306
Okayama, , Japan
Local Institution - 1308
Shimotsuke-shi, Tochigi, , Japan
Local Institution - 1355
Saltillo, Coahuila, Mexico
Local Institution - 1356
Mexico City, Mexico City, Mexico
Local Institution - 1350
Monterrey, Nuevo León, Mexico
Local Institution - 1361
Mexico City, , Mexico
Local Institution - 1363
Mexico City, , Mexico
Local Institution - 1360
Mexico City, , Mexico
Local Institution - 1364
Monterrey, , Mexico
Local Institution - 1362
San Luis Potosí City, , Mexico
Local Institution - 1352
Tlalnepantla, , Mexico
Local Institution - 1401
Coimbra, , Portugal
Local Institution - 1402
Guimarães, , Portugal
Local Institution - 1404
Lisbon, , Portugal
Local Institution - 1403
Senhora da Hora, , Portugal
Local Institution - 1400
Torres Vedras, , Portugal
Local Institution - 1450
Bucharest, București, Romania
Local Institution - 1452
Bucharest, București, Romania
Local Institution - 1453
Bucharest, București, Romania
Local Institution - 1454
Bucharest, București, Romania
Local Institution - 1455
Bucharest, București, Romania
Local Institution - 1456
Bucharest, București, Romania
Local Institution - 1458
Bucharest, București, Romania
Local Institution - 1451
Bucharest, , Romania
Local Institution - 1459
Bucharest, , Romania
Local Institution - 1461
Constanța, , Romania
Local Institution - 1457
Iași, , Romania
Local Institution - 1460
Sanpetru /Brasov, , Romania
Local Institution - 1462
Sibiu, , Romania
Local Institution - 1510
Getxo, Bizkaia, Spain
Local Institution - 1509
Elche (alicante), , Spain
Local Institution - 1508
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Local Institution - 1502
Málaga, , Spain
Local Institution - 1507
Pamplona, , Spain
Local Institution - 1500
Salamanca, , Spain
Local Institution - 1503
Seville, , Spain
Local Institution - 1504
Terrassa, , Spain
Local Institution - 1506
Valladolid, , Spain
Local Institution - 1501
Zaragoza, , Spain
Local Institution - 1753
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Local Institution - 1751
Tainan, Taiana, , Taiwan
Local Institution - 1754
Taipei, , Taiwan
Local Institution - 1750
Taipei, , Taiwan
Local Institution - 1752
Taoyuan District, , Taiwan
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Nida Laurin, Site 1619
Role: primary
Steven Macina, Site 1657
Role: primary
Janne Nissinen, Site 1637
Role: primary
Site 1662
Role: primary
Marina Raikhel, Site 1639
Role: primary
Ira Glick, Site 1651
Role: primary
Site 1622
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Site 1631
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Site 1602
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Site 1618
Role: primary
Jorge Jorge, Site 1609
Role: primary
Jorge Betancourt, MD, Site 1604
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Site 1608
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Eric Carbonell, Site 1635
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Alexander White, Site 1612
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Site 1661
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Site 1655
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Elia Acevedo Diaz, Site 1636
Role: primary
Site 1663
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Paul Solomon, Site 1638
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Simon Desjardins, Site 1642
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Site 1660
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Site 1665
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Jay Sandberg, Site 1620
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Jelena Kunovac, Site 1649
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Matthew Davis, Site 1647
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Site 1664
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Site 1610
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Site 1656
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Site 1658
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Site 1601
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Site 1659
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Sarah Land, Site 1640
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Site 1653
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Aamr Herekar, Site 1643
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Site 1641
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Site 1646
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Site 1644
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Site 1654
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Site 1001
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Site 1002
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Site 1006
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Site 1003
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Site 1004
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Site 1005
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Site 1000
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Site 1051
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Site 1052
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Site 1053
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Site 1058
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Site 1054
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Site 1057
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Site 1056
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Site 1050
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Site 1055
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Site 1100
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Site 1101
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Site 1103
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Site 1102
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Site 1153
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Site 1155
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Site 1151
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Site 1154
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Site 1152
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Site 1150
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Site 1805
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Site 1810
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Site 1815
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Site 1809
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Site 1802
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Site 1801
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Site 1800
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Site 1816
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Site 1814
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Site 1804
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Site 1812
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Site 1550
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Site 1553
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Site 1554
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Site 1551
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Site 1552
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Site 1200
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Site 1205
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Site 1202
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Site 1206
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Site 1203
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Site 1207
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Site 1201
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Site 1204
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Site 1251
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Site 1255
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Site 1252
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Site 1254
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Site 1250
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Site 1256
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Site 1253
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Site 1301
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Site 1307
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Site 1304
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Site 1303
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Site 1300
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Site 1305
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Site 1302
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Site 1306
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Site 1308
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Site 1355
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Site 1356
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Site 1350
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Site 1361
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Site 1363
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Site 1360
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Site 1364
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Site 1362
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Site 1352
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Site 1401
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Site 1402
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Site 1404
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Site 1403
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Site 1400
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Site 1450
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Site 1454
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Site 1455
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Site 1456
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Site 1458
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Site 1451
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Site 1459
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Site 1461
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Site 1457
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Site 1460
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Site 1462
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Site 1510
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Site 1509
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Site 1508
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Jordi Matias Guiu, Site 1505
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Site 1502
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Site 1507
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Site 1500
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Site 1503
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Site 1504
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Site 1506
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Site 1501
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Site 1753
Role: primary
Site 1751
Role: primary
Site 1754
Role: primary
Site 1750
Role: primary
Site 1752
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-520613-31
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1316-5745
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0023
Identifier Type: -
Identifier Source: org_study_id