A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
NCT ID: NCT06937229
Last Updated: 2026-01-08
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
600 participants
INTERVENTIONAL
2025-12-02
2029-07-20
Brief Summary
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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)
NCT07011732
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-2)
NCT07011745
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT and KarXT + KarX-EC in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
NCT05980949
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
NCT06585787
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
NCT06976216
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KarXT+KarX-EC
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).
Exclusion Criteria
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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Local Institution - 2609
Chandler, Arizona, United States
Local Institution - 1619
Scottsdale, Arizona, United States
Local Institution - 1657
Anaheim, California, United States
Local Institution - 2620
Canoga Park, California, United States
Local Institution - 1637
La Jolla, California, United States
Local Institution - 2625
Long Beach, California, United States
Local Institution - 2607
Long Beach, California, United States
Local Institution - 2642
Long Beach, California, United States
Local Institution - 2613
Pasadena, California, United States
Local Institution - 1662
Pomona, California, United States
Local Institution - 2614
San Diego, California, United States
Local Institution - 1651
Walnut Creek, California, United States
Local Institution - 2602
Bonita Springs, Florida, United States
Local Institution - 2626
Hialeah, Florida, United States
Local Institution - 1602
Miami, Florida, United States
Local Institution - 1618
Miami, Florida, United States
Local Institution - 1609
Miami, Florida, United States
Nuovida Research Center
Miami, Florida, United States
Local Institution - 1635
Orlando, Florida, United States
Local Institution - 1612
Port Orange, Florida, United States
Local Institution - 2621
Tampa, Florida, United States
Local Institution - 1636
Gaithersburg, Maryland, United States
Local Institution - 1638
Newton, Massachusetts, United States
Local Institution - 2615
Worcester, Massachusetts, United States
Local Institution - 2618
Ann Arbor, Michigan, United States
Local Institution - 1620
Troy, Michigan, United States
Local Institution - 2256
Saint Paul, Minnesota, United States
Local Institution - 2629
Hattiesburg, Mississippi, United States
Local Institution - 2628
Las Vegas, Nevada, United States
Local Institution - 1649
Las Vegas, Nevada, United States
Local Institution - 1647
West Long Branch, New Jersey, United States
Local Institution - 1656
New Windsor, New York, United States
Local Institution - 2619
Staten Island, New York, United States
Local Institution - 1658
Woodmere, New York, United States
Local Institution - 1601
Monroe, North Carolina, United States
Local Institution - 2608
Morehead City, North Carolina, United States
Local Institution - 2617
Blue Ash, Ohio, United States
Local Institution - 1640
Tulsa, Oklahoma, United States
Local Institution - 1653
Columbia, South Carolina, United States
Local Institution - 2616
Carrollton, Texas, United States
Local Institution - 2605
Cypress, Texas, United States
Local Institution - 1643
El Paso, Texas, United States
Local Institution - 2622
Mesquite, Texas, United States
Local Institution - 2623
San Antonio, Texas, United States
Pantheon Clinical Research, LLC
Bountiful, 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 - 2610
Milwaukee, Wisconsin, United States
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 1001
La Plata, Buenos Aires, Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina
Local Institution - 2006
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 1006
Rosario, Santa Fe Province, Argentina
Local Institution - 2004
Buenos Aires, , Argentina
Local Institution - 1003
Buenos Aires, , Argentina
Local Institution - 1004
Córdoba, , Argentina
Local Institution - 2000
Córdoba, , Argentina
Local Institution - 2002
Córdoba, , Argentina
Local Institution - 1005
Córdoba, , Argentina
Local Institution - 1000
Córdoba, , Argentina
Local Institution - 2003
Córdoba, , Argentina
Local Institution - 2001
Mendoza, , Argentina
Local Institution - 1051
BrasÃlia, Federal District, Brazil
Local Institution - 1053
Curitiba, Paraná, Brazil
Local Institution - 1052
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 - 1151
Toronto, Ontario, Canada
Local Institution - 1154
Toronto, Ontario, Canada
Local Institution - 1152
Whitby, Ontario, Canada
Local Institution - 2055
Viña del Mar, Región de ValparaÃso, Chile
Local Institution - 2051
Santiago, Santiago Metropolitan, Chile
Local Institution - 2052
Santiago, Santiago Metropolitan, Chile
Local Institution - 2054
Vitacura, Santiago Metropolitan, Chile
Local Institution - 2053
Antofagasta, , Chile
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 - 1550
Zagreb, , Croatia
Local Institution - 2107
Olomouc, Olomoucký kraj, Czechia
Local Institution - 2100
Prague, Praha 6, Czechia
Local Institution - 2106
Prague, Praha 8, Czechia
Local Institution - 2103
Brno, South Moravian, Czechia
Local Institution - 2101
Choceň, , Czechia
Local Institution - 2104
Pilsen, , Czechia
Local Institution - 2102
Prague, , Czechia
Local Institution - 2105
Prague, , Czechia
Local Institution - 2108
Rychnov nad Kněžnou, , Czechia
Local Institution - 2150
Toulouse, Haute-Garonne, France
Local Institution - 2151
Villeurbanne, Rhône, France
Local Institution - 2153
Lille, , France
Local Institution - 2156
Limoges, , France
Local Institution - 2157
Montpellier, , France
Local Institution - 2152
Paris, , France
Local Institution - 2155
Strasbourg, , France
Local Institution - 2203
Erbach im Odenwald, Hesse, Germany
Local Institution - 2201
Düsseldorf, , Germany
Local Institution - 2205
Halle, , Germany
Local Institution - 2206
Westerstede, , Germany
Local Institution - 1200
Pátrai, Achaḯa, Greece
Local Institution - 1205
Athens, Attica, Greece
Local Institution - 1202
Athens, Attica, Greece
Local Institution - 1203
Chaïdári, AttikÃ, Greece
Local Institution - 0027
Athens, , Greece
Local Institution - 1206
Athens, , Greece
Local Institution - 1207
Athens, , Greece
Local Institution - 1201
Ioannina, , Greece
Local Institution - 1204
Thessaloniki, , Greece
Local Institution - 2257
Kalocsa, Bács-Kiskun county, Hungary
Local Institution - 2250
Győr, Győr-Moson-Sopron, Hungary
Local Institution - 2254
Gyöngyös, Heves County, Hungary
Local Institution - 2255
Budapest, , Hungary
Local Institution - 2251
Budapest, , Hungary
Local Institution - 2253
Budapest, , Hungary
Local Institution - 2252
Debrecen, , Hungary
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 - 2304
Rishon Le'Tzion, Central District, Israel
Local Institution - 2302
Petch Tikva, IL, Israel
Local Institution - 2301
Jerusalem, , Israel
Local Institution - 2303
Netanya, , Israel
Local Institution - 2305
Ramat Gan, , Israel
Local Institution - 2300
Ramat Gan, , Israel
Local Institution - 2351
Napoli, Campania, Italy
Local Institution - 2354
Rome, Lazio, Italy
Local Institution - 2352
Rome, Lazio, Italy
Local Institution - 2353
Milan, Lombardy, Italy
Local Institution - 2350
Pisa, PI, Italy
Local Institution - 2356
Brescia, , Italy
Local Institution - 2355
Isernia, , Italy
Local Institution - 2357
Roma, , Italy
Local Institution - 1301
Hadano, Kanagawa, Japan
Local Institution - 1307
Kawasaki, Kanagawa, Japan
Local Institution - 1304
Sakai, Osaka, Japan
National Hospital Organization Hizen Psychiatric Center
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
Guadajalara, Jalisco, 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 Potosà City, , Mexico
Local Institution - 1352
Tlalnepantla, , Mexico
Local Institution - 2450
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 2454
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 2456
Chorzów, , Poland
Local Institution - 2455
Katowice, , Poland
Local Institution - 2451
Lublin, , Poland
Local Institution - 2452
Lublin, , Poland
Local Institution - 2453
Sochaczew, , Poland
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 - 2401
Incheon, Incheon Gwang'yeogsi, South Korea
Local Institution - 2407
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2403
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2400
Deagu, Taegu-KwangyÇ’kshi, South Korea
Local Institution - 2409
Incheon, , South Korea
Local Institution - 2402
Seoul, , South Korea
Local Institution - 2408
Seoul, , South Korea
Local Institution - 2405
Seoul, , South Korea
Local Institution - 2404
Seoul, , South Korea
Local Institution - 1510
Getxo, Bizkaia, Spain
Local Institution - 1509
Elche (alicante), , Spain
Local Institution - 1508
Madrid, , Spain
Local Institution - 1505
Madrid, , Spain
Local Institution - 0003
Málaga, , 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
Local Institution - 2555
Smila, Cherkasy Oblast, Ukraine
Local Institution - 2554
Dnipro, Dnipropetrovsk Oblast, Ukraine
Local Institution - 2559
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine
Local Institution - 2556
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 2566
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 2553
Kyiv, Kyivska Oblast, Ukraine
Local Institution - 2552
Lviv, Lviv Oblast, Ukraine
Local Institution - 2558
Lviv, Lviv Oblast, Ukraine
Local Institution - 2569
Lviv, Lviv Oblast, Ukraine
Local Institution - 2567
Oleksandrivka, Odesa Oblast, Ukraine
Local Institution - 2551
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 2550
Kropyvnytskyi, , Ukraine
Local Institution - 2568
Odesa, , Ukraine
Local Institution - 2505
Preston, Lancashire, United Kingdom
Local Institution - 2508
Chertsey, Surrey, United Kingdom
Local Institution - 2502
Cambridge, , United Kingdom
Local Institution - 2501
London, , United Kingdom
Local Institution - 2500
London, , United Kingdom
Local Institution - 2510
Motherwell, , United Kingdom
Local Institution - 2507
Redruth, , United Kingdom
Local Institution - 2504
Sheffield, , United Kingdom
Local Institution - 2509
Stafford, , United Kingdom
Local Institution - 2503
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center, www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site 2609
Role: primary
Site 1619
Role: primary
Site 1657
Role: primary
Site 2620
Role: primary
Site 1637
Role: primary
Site 2625
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Site 2607
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Site 2642
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Site 2613
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Site 1662
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Site 2614
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Site 1651
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Site 2602
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Site 2626
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Site 1602
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Site 1618
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Site 1609
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Jorge Betancourt, MD, Site 1604
Role: primary
Site 1635
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Site 1612
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Site 2621
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Site 1636
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Site 1638
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Site 2615
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Site 2618
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Site 1620
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Site 2256
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Site 2629
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Site 2628
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Site 1649
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Site 1647
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Site 1656
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Site 2619
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Site 1658
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Site 1601
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Site 2608
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Site 2617
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Site 1640
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Site 1653
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Site 2616
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Site 2605
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Site 1643
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Site 2622
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Site 2623
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Jackson Rhudy, Site 2612
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Site 1646
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Site 1644
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Site 1654
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Site 2610
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Site 2005
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Site 1001
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Site 1002
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Site 2006
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Site 1006
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Site 2004
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Site 1003
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Site 1004
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Site 2000
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Site 2002
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Site 1005
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Site 1000
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Site 2003
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Site 2001
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Site 1051
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Site 1053
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Site 1052
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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 2055
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Site 2051
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Site 2052
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Site 2054
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Site 2053
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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 1550
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Site 2107
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Site 2100
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Site 2106
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Site 2103
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Site 2101
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Site 2104
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Site 2108
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Site 2150
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Site 2151
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Site 2153
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Site 2156
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Site 2157
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Site 2152
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Site 2155
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Site 2203
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Site 2201
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Site 2205
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Site 2206
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Site 1200
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Site 1205
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Site 1202
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Site 1203
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Site 1206
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Site 1207
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Site 1201
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Site 1204
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Site 2257
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Site 2250
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Site 2254
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Site 2255
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Site 2253
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Site 2252
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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 2304
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Site 2302
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Site 2301
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Site 2303
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Site 2305
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Site 2300
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Site 2351
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Site 2354
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Site 2352
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Site 2353
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Site 2350
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Site 2356
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Site 2357
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Site 1301
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Site 1307
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Site 1304
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Manabu Hashimoto, 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 1350
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Site 1360
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Site 1364
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Site 1352
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Site 2450
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Site 2454
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Site 2451
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Site 2453
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Site 1401
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Site 1402
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Site 1403
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Site 1400
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Site 1450
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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 2401
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Site 2407
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Site 2403
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Site 2400
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Site 2409
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Site 2402
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Site 2408
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Site 2405
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Site 2404
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Site 1510
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Site 1509
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Site 1508
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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 1506
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Site 1501
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Site 1753
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Site 1751
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Site 1754
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Site 1750
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Site 2555
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Site 2554
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Site 2559
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Site 2556
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Site 2566
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Site 2553
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Site 2552
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Site 2558
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Site 2569
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Site 2567
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Site 2551
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Site 2550
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Site 2568
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Site 2505
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Site 2508
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Site 2502
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Site 2501
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Site 2500
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Site 2510
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Site 2507
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Site 2504
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Site 2503
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-519994-20
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1316-3903
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0025
Identifier Type: -
Identifier Source: org_study_id
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