AXIOMATIC-SSP: A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Study Details
Study Description
Brief Summary
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: BMS-986177 Placebo Specified Dose on Specified Days |
Other: Placebo
Oral Administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177
Oral administration
Drug: Clopidogrel
Oral administration
Drug: Aspirin
Oral administration
|
Outcome Measures
Primary Outcome Measures
- Composite of new ischemic stroke during the treatment period and new covert brain infarction (FLAIR + DWI) detected by MRI [Up to 90 days]
Secondary Outcome Measures
- Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [Up to 90 days]
- Event rate based on BARC, International Society on Thrombosis and Hemostasis (ISTH) and Platelet Inhibition and Patient Outcomes (PLATO)-defined criteria [Up to 90 days]
- Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period [Up to 90 days]
- Location of new FLAIR + DWI lesions [Up to 90 days]
- Number of new FLAIR + DWI lesions [Up to 90 days]
- Volume of new FLAIR + DWI lesions [Up to 90 days]
- Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction and all-cause death during the treatment period [Up to 90 days]
- Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS) [Day 21 and Day 90]
- Assessment of Neurological function by the modified Rankin Scale (mRS) [Day 21 and Day 90]
- Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA) [Day 21 and Day 90]
- Incidence of Adverse Events (AEs) [First dose up to 97 days]
- Incidence of Serious Adverse Events (SAEs) [First dose up to 97 days]
- Change from Baseline in Heart Rate [Up to 90 Days]
- Change from Baseline in Blood Pressure [Up to 90 Days]
- Change from Baseline in Respiratory Rate [Up to 90 Days]
- Change from Baseline in Body Temperature [Up to 90 Days]
- Incidence of Abnormalities in Physical Examination [Up to 90 days]
- Incidence of Electrocardiogram (ECG) abnormalities [Up to 90 Days]
- Change from baseline in Clinical Laboratory Value of blood [Up to 90 Days]
- Change from baseline in Clinical Laboratory Value of Urine [Up to 90 Days]
- Change from baseline in Clinical Laboratory Value of Blood Serum [Up to 90 Days]
- Change from Baseline in Estimated Clearance (CL) [Up to 90 Days]
- Change from Baseline in Volume of Distribution (Vd) [Up to 90 days]
- Percent change from baseline in aPTT clotting activity during treatment [Up to 90 Days]
- Percent change from baseline in Factor XI clotting activity during treatment [Up to 90 Days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and Female ≥40 years of age
-
Acute Ischemic Stroke or Transient Ischemic Attack
-
Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area
Exclusion Criteria:
-
Predicted inability to swallow study medication
-
Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
-
Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham: The Kirklin Clinic | Birmingham | Alabama | United States | 35233 |
2 | Glendale Adventist Medical Center | Glendale | California | United States | 91206 |
3 | Long Beach Memorial Medical Center | Long Beach | California | United States | 90806 |
4 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
5 | UCLA Ronald Reagan University of California Los Angeles Medical Center | Los Angeles | California | United States | 90095 |
6 | UC Davis Health | Sacramento | California | United States | 95817 |
7 | Stanford Stroke Center | Stanford | California | United States | 94305 |
8 | Harbor UCLA Medical Center | Torrance | California | United States | 90502 |
9 | Christiana Care Health System | Newark | Delaware | United States | 19718 |
10 | UF Health Neurovascular Hospital | Gainesville | Florida | United States | 32610 |
11 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
12 | University of South Florida | Tampa | Florida | United States | 33606 |
13 | Augusta University | Augusta | Georgia | United States | 30912 |
14 | The Queens Medical Center | Honolulu | Hawaii | United States | 96813 |
15 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
16 | University of Illinois Hospital & Health Sciences System | Chicago | Illinois | United States | 60612 |
17 | Alexian Brothers Health System | Elk Grove Village | Illinois | United States | 60007 |
18 | Mercyhealth Javon Bea Hospital- Riverside | Rockford | Illinois | United States | 61114 |
19 | University of Louisville Hospital | Louisville | Kentucky | United States | 40202 |
20 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
21 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
22 | Local Institution | Boston | Massachusetts | United States | 02118 |
23 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
24 | Local Institution | Detroit | Michigan | United States | 48201 |
25 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
26 | Local Institution | Detroit | Michigan | United States | 48235 |
27 | Ascension Providence Hospital - Novi Campus | Farmington Hills | Michigan | United States | 48334 |
28 | Local Institution | Minneapolis | Minnesota | United States | 55415 |
29 | Local Institution | Kansas City | Missouri | United States | 64111 |
30 | Local Institution | Saint Louis | Missouri | United States | 63104 |
31 | Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
32 | Washington University School Of Medicine | Saint Louis | Missouri | United States | 63110 |
33 | Advanced Neurology Specialists PLLC | Great Falls | Montana | United States | 59405 |
34 | Cooper University Hospital | Camden | New Jersey | United States | 08103 |
35 | Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08901 |
36 | SUNY Downstate Health Science University | Brooklyn | New York | United States | 11203 |
37 | Local Institution | Buffalo | New York | United States | 14202 |
38 | Local Institution | New York | New York | United States | 10016 |
39 | Columbia University Medical Center | New York | New York | United States | 10032 |
40 | Duke University Medical Center | Butner | North Carolina | United States | 27509-1626 |
41 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
42 | Guilford Neurologic Research, PA | Greensboro | North Carolina | United States | 27405 |
43 | Local Institution | Winston-Salem | North Carolina | United States | 27157 |
44 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106-5055 |
45 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
46 | The Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
47 | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112 |
48 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
49 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
50 | Local Institution | Allentown | Pennsylvania | United States | 18103-6381 |
51 | Local Institution | Camp Hill | Pennsylvania | United States | 17011 |
52 | UPMC Hamot | Erie | Pennsylvania | United States | 16550-0001 |
53 | Hospital of The University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
54 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
55 | WellSpan York Hospital | York | Pennsylvania | United States | 17403 |
56 | Prisma Health-Midlands | Columbia | South Carolina | United States | 29203 |
57 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
58 | Dell Seton Medical School at The University of Texas - Stroke Institute | Austin | Texas | United States | 78701 |
59 | Neurology Consultants of Dallas, PA | Dallas | Texas | United States | 75321 |
60 | Local Institution | Dallas | Texas | United States | 75390-88520 |
61 | University Medical center of El Paso | El Paso | Texas | United States | 79905 |
62 | Methodist Neurological Institute | Houston | Texas | United States | 77030 |
63 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
64 | Baylor Scott and White Research Institute | Temple | Texas | United States | 76508 |
65 | Local Institution | Richmond | Virginia | United States | 23298 |
66 | Local Institution | Milwaukee | Wisconsin | United States | 53226 |
67 | Local Institution | Caba | Buenos Aires | Argentina | 1115 |
68 | Local Institution | Caba | Buenos Aires | Argentina | C1199ABB |
69 | Local Institution | Caba | Buenos Aires | Argentina | C1428AQK |
70 | Local Institution | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | C1180AAX |
71 | Local Institution | Lomas de Zamora | Buenos Aires | Argentina | 1832 |
72 | Local Institution | Buenos Aires | Argentina | 1437 | |
73 | Local Institution | Buenos Aires | Argentina | C1425DND | |
74 | Local Institution | Buenos Aires | Argentina | C1425 | |
75 | Local Institution | Santa Fe | Argentina | 3000 | |
76 | Local Institution | Randwick | New South Wales | Australia | 2031 |
77 | Local Institution | Sydney | New South Wales | Australia | 2170 |
78 | Local Institution | Southport | Queensland | Australia | 4215 |
79 | Local Institution | Adelaide | South Australia | Australia | 5000 |
80 | Local Institution | Launceston | Tasmania | Australia | 7250 |
81 | Local Institution | Clayton | Victoria | Australia | 3168 |
82 | Local Institution | Heidelberg | Victoria | Australia | 3084 |
83 | Local Institution | Murdoch | Western Australia | Australia | 6150 |
84 | Local Institution | Klagenfurt Am Woerthersee | Austria | 9020 | |
85 | Local Institution | St. Pölten | Austria | 3100 | |
86 | Local Institution | Vocklabruck | Austria | 4840 | |
87 | Local Institution | Wien | Austria | 1160 | |
88 | Local Institution - 0192 | Yvoir | Namur | Belgium | 5530 |
89 | Local Institution | Brasschaat | Belgium | 2930 | |
90 | Local Institution | Bruges | Belgium | 8000 | |
91 | Local Institution | Brussels | Belgium | 1020 | |
92 | Local Institution | Brussels | Belgium | 1200 | |
93 | Local Institution | Brussel | Belgium | 1090 | |
94 | Local Institution | Bruxelles | Belgium | 1070 | |
95 | Local Institution | Edegem | Belgium | 2650 | |
96 | Local Institution | Gent | Belgium | 9000 | |
97 | Local Institution | Kortrijk | Belgium | 8500 | |
98 | Local Institution | Leuven | Belgium | 3000 | |
99 | Local Institution | Liege | Belgium | 4000 | |
100 | Local Institution | Fortaleza | Ceara | Brazil | 60175-295 |
101 | Local Institution | Uberaba | Minas Gerais | Brazil | 38025-260 |
102 | Local Institution | Curitiba | Parana | Brazil | 80060-900 |
103 | Local Institution | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-903 |
104 | Local Institution | Joinville | Santa Catarina | Brazil | 89202 165 |
105 | Local Institution | Botucatu | SAO Paulo | Brazil | 18618-686 |
106 | Local Institution | Campinas | SAO Paulo | Brazil | 13083-970 |
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108 | Local Institution | Santo Andre | SAO Paulo | Brazil | 09030-010 |
109 | Local Institution | São Paulo | SAO Paulo | Brazil | 01221-020 |
110 | Local Institution | São Paulo | SAO Paulo | Brazil | 04024-002 |
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118 | Local Institution | London | Ontario | Canada | N6A 5A5 |
119 | Local Institution | Toronto | Ontario | Canada | M4N 3M5 |
120 | Local Institution | Toronto | Ontario | Canada | M5B 1W8 |
121 | Local Institution | Chicoutimi | Quebec | Canada | G7H 5H6 |
122 | Local Institution | Greenfield Park | Quebec | Canada | J4V 2H1 |
123 | Local Institution | Montreal | Quebec | Canada | H4A3J1 |
124 | Local Institution | Quebec | Canada | G1J 1Z4 | |
125 | Local Institution | Valdivia | Los Rios | Chile | 5090145 |
126 | Local Institution | Vina del Mar | Valparaiso | Chile | 2520997 |
127 | Local Institution | Los Angeles | Chile | 441055 | |
128 | Local Institution | Beijing | Beijing | China | 100070 |
129 | Local Institution | Guangzhou | Guangdong | China | 510080 |
130 | Local Institution | Haikou | Hainan | China | 570311 |
131 | Local Institution | Daqing | Heilongjiang | China | 163001 |
132 | Local Institution | Zhengzhou | Henan | China | 450052 |
133 | Local Institution | Nantong | Jiangsu | China | 226001 |
134 | Local Institution | Yangzhou | Jiangsu | China | 225001 |
135 | Local Institution | Changchun | Jilin | China | 130021 |
136 | Local Institution | Shenyang | Liaoning | China | 110016 |
137 | Local Institution | Qingdao | Shandong | China | 266000 |
138 | Local Institution | YanTai | Shandong | China | 264000 |
139 | Local Institution | Wenzhou | Zhejiang | China | 325000 |
140 | Local Institution | Brno | Czechia | 656 91 | |
141 | Local Institution | Ceske Budejovice | Czechia | 370 87 | |
142 | Local Institution | Jihlava | Czechia | 586 33 | |
143 | Local Institution | Olomouc | Czechia | 77520 | |
144 | Local Institution | Ostrava | Czechia | 703 00 | |
145 | Local Institution | Praha 2 | Czechia | 128 21 | |
146 | Local Institution | Aalborg | Denmark | 9000 | |
147 | Local Institution | Aarhus N | Denmark | 8200 | |
148 | Local Institution | Copenhagen | Denmark | 2400 | |
149 | Local Institution | Glostrup | Denmark | 2600 | |
150 | Local Institution | Herlev | Denmark | 2730 | |
151 | Local Institution - 0111 | Helsinki | Etelä-Suomen Lääni | Finland | 00290 |
152 | Local Institution | Lappeenranta | Finland | 53130 | |
153 | Local Institution | Turku | Finland | FI-20520 | |
154 | Local Institution | Bordeaux | France | 33000 | |
155 | Local Institution | Bourg-en-Bresse | France | 01012 | |
156 | Local Institution | Brest | France | 29200 | |
157 | Local Institution | Caen | France | 14033 | |
158 | Local Institution | Créteil | France | 94010 | |
159 | Local Institution | Lille | France | 59037 | |
160 | Local Institution | Limoges Cedex | France | 87042 | |
161 | Local Institution | Marseille | France | 13385 | |
162 | Local Institution | Montpellier Cedex 5 | France | 34295 | |
163 | Local Institution | Nancy | France | 54035 | |
164 | Local Institution | Nimes | France | 30029 | |
165 | Local Institution | Paris cedex 10 | France | 75475 | |
166 | Local Institution | Paris | France | 75013 | |
167 | Local Institution | Paris | France | 75018 | |
168 | Local Institution | Paris | France | 75019 | |
169 | Local Institution | Rouen Cedex | France | 76031 | |
170 | Local Institution | Toulouse Cedex 9 | France | 31059 | |
171 | Local Institution | Altenburg | Germany | 04600 | |
172 | Local Institution | Berlin | Germany | 12203 | |
173 | Local Institution | Berlin | Germany | 12351 | |
174 | Local Institution | Bielefeld | Germany | 33617 | |
175 | Local Institution | Bonn | Germany | 53127 | |
176 | Local Institution | Bremen | Germany | 28755 | |
177 | Local Institution | Dresden | Germany | 01307 | |
178 | Local Institution | Erlangen | Germany | 91054 | |
179 | Local Institution | Essen | Germany | 45131 | |
180 | Local Institution | Frankfurt Am Maim | Germany | 65929 | |
181 | Local Institution | Frankfurt am Main | Germany | 60528 | |
182 | Local Institution | Gießen | Germany | 35392 | |
183 | Local Institution - 0056 | Hamburg | Germany | 20246 | |
184 | Local Institution | Hamburg | Germany | 22043 | |
185 | Local Institution | Hamburg | Germany | 22763 | |
186 | Local Institution | Hannover | Germany | D30625 | |
187 | Local Institution | Heidelberg | Germany | 69120 | |
188 | Local Institution | Leipzig | Germany | 04103 | |
189 | Local Institution | Lübeck | Germany | 23538 | |
190 | Local Institution | Magdeburg | Germany | 39120 | |
191 | Local Institution | Minden | Germany | 32429 | |
192 | Local Institution | Munster | Germany | 48149 | |
193 | Local Institution | Osnabruck | Germany | 49076 | |
194 | Local Institution | Regensburg | Germany | 93053 | |
195 | Local Institution | Sande | Germany | 26452 | |
196 | Local Institution | Siegen | Germany | 57076 | |
197 | Local Institution | Sindelfingen | Germany | 71065 | |
198 | Local Institution | Tubingen | Germany | 72076 | |
199 | Local Institution | Ulm | Germany | 89081 | |
200 | Local Institution - 0438 | Athina | Attiki | Greece | 115 21 |
201 | Local Institution | Athens | Greece | 106 76 | |
202 | Local Institution | Athens | Greece | 11525 | |
203 | Local Institution | Athens | Greece | 11526 | |
204 | Local Institution - 0373 | Athens | Greece | 11527 | |
205 | Local Institution | Athens | Greece | 11527 | |
206 | Local Institution | Athens | Greece | 11528 | |
207 | Local Institution | Athens | Greece | 12461 | |
208 | Local Institution | Crete | Greece | 71110 | |
209 | Local Institution - 0333 | Ioannina | Greece | 45110 | |
210 | Local Institution - 0365 | Ioannina | Greece | 45110 | |
211 | Local Institution | Ioannina | Greece | 45445 | |
212 | Local Institution | Larissa, | Greece | 41110 | |
213 | Local Institution | Larissa | Greece | 41110 | |
214 | Local Institution | Larissa | Greece | 41221 | |
215 | Local Institution | Neo Faliro | Greece | 18547 | |
216 | Local Institution | Patras | Greece | 26500 | |
217 | Local Institution | Pireaus | Greece | 18536 | |
218 | Local Institution | Thessaloniki | Greece | 54621 | |
219 | Local Institution | Thessaloniki | Greece | 54636 | |
220 | Local Institution | Thessaloniki | Greece | 54642 | |
221 | Local Institution | Thessaloniki | Greece | 56403 | |
222 | Local Institution | Thessaloniki | Greece | 57010 | |
223 | Local Institution | Hong Kong | Hong Kong | ||
224 | Local Institution | Budapest | Hungary | 1083 | |
225 | Local Institution | Budapest | Hungary | 1106 | |
226 | Local Institution | Budapest | Hungary | 1134 | |
227 | Local Institution | Budapest | Hungary | 1145 | |
228 | Local Institution | Debrecen | Hungary | 4032 | |
229 | Local Institution | Gyor | Hungary | 9024 | |
230 | Local Institution | Kistarcsa | Hungary | 02143 | |
231 | Local Institution | Kisvárda | Hungary | 4600 | |
232 | Local Institution | Miskolc | Hungary | 3526 | |
233 | Local Institution | Nyíregyháza | Hungary | 4400 | |
234 | Local Institution | Pecs | Hungary | 7624 | |
235 | Local Institution - 0133 | Szeged | Hungary | 6725 | |
236 | Local Institution | Zalaegerszeg | Hungary | 8900 | |
237 | Local Institution | Beer-Sheva | Israel | 85025 | |
238 | Local Institution | Haifa | Israel | 31096 | |
239 | Local Institution | Haifa | Israel | 34362 | |
240 | Local Institution | Jerusalem | Israel | 91031 | |
241 | Local Institution | Jerusalem | Israel | 91120 | |
242 | Local Institution | Nahariya | Israel | 22100 | |
243 | Local Institution | Petach Tikva | Israel | 4941492 | |
244 | Local Institution | Ramat-Gan | Israel | 52621 | |
245 | Local Institution | Tel Aviv | Israel | 64239 | |
246 | Local Institution - 0151 | Ancona | Marche | Italy | 60020 |
247 | Local Institution | Bologna | Italy | 40133 | |
248 | Local Institution | Cagliari | Italy | 09134 | |
249 | Local Institution | Genova | Italy | 16132 | |
250 | Local Institution | Milano | Italy | 20132 | |
251 | Local Institution | Modena | Italy | 1355-41126 | |
252 | Local Institution | Negrar | Italy | 37024 | |
253 | Local Institution | Pavia | Italy | 27100 | |
254 | Local Institution | Perugia | Italy | 06012 | |
255 | Local Institution | Perugia | Italy | 06129 | |
256 | Local Institution | Roma | Italy | 00161 | |
257 | Local Institution | Rome | Italy | 00152 | |
258 | Local Institution | Verona | Italy | 37126 | |
259 | Local Institution | Vibo Valentia | Italy | 89900 | |
260 | Local Institution | Kasugai | Aichi | Japan | 487-0016 |
261 | Local Institution | Nagoya-shi | Aichi | Japan | 4600001 |
262 | Local Institution | Toyoake Shi | Aichi | Japan | 4701192 |
263 | Local Institution | Toyohashi-shi | Aichi | Japan | 440-8510 |
264 | Local Institution | Toyota-shi | Aichi | Japan | 471-8513 |
265 | Local Institution | Sakura-shi | Chiba | Japan | 285-8741 |
266 | Local Institution | Chikushino-shi | Fukuoka | Japan | 818-8516 |
267 | Local Institution | Kasuga-shi | Fukuoka | Japan | 816-0864 |
268 | Local Institution | Kitakyushu-shi | Fukuoka | Japan | 802-8555 |
269 | Local Institution | Kitakyushu-shi | Fukuoka | Japan | 8058508 |
270 | Local Institution | Kitakyushu | Fukuoka | Japan | 800-0296 |
271 | Local Institution | Koga-shi | Fukuoka | Japan | 811-3113 |
272 | Local Institution | Kurume City | Fukuoka | Japan | 830-8577 |
273 | Local Institution | Aizuwakamatsu-shi | Fukushima | Japan | 9658585 |
274 | Local Institution | Takayama-shi | Gifu | Japan | 506-8550 |
275 | Local Institution | Isesaki-shi | Gunma | Japan | 3720006 |
276 | Local Institution | Aki-gun | Hiroshima | Japan | 735-8585 |
277 | Local Institution | Higashihiroshima-shi | Hiroshima | Japan | 739-0041 |
278 | Local Institution | Hiroshima-shi | Hiroshima | Japan | 731-0293 |
279 | Local Institution | Kobe-City | Hyogo | Japan | 650-0047 |
280 | Local Institution | Kanazawa | Ishikawa | Japan | 920-8650 |
281 | Local Institution | Komatsu | Ishikawa | Japan | 923-8560 |
282 | Local Institution | Kagoshima-shi | Kagoshima | Japan | 890-8760 |
283 | Local Institution | Kawasaki-city | Kanagawa | Japan | 216-8511 |
284 | Local Institution | Kawasaki | Kanagawa | Japan | 211-0063 |
285 | Local Institution | Sendai-shi | Miyagi | Japan | 982-8523 |
286 | Local Institution | Sendai | Miyagi | Japan | 9838520 |
287 | Local Institution | Nagasaki-shi | Nagasaki | Japan | 8528501 |
288 | Local Institution | Izumisano-shi | Osaka | Japan | 5988577 |
289 | Local Institution | Kishiwada | Osaka | Japan | 596-8522 |
290 | Local Institution | Matsubara | Osaka | Japan | 580-0032 |
291 | Local Institution | Sakai-shi | Osaka | Japan | 590-0064 |
292 | Local Institution | Suita-shi | Osaka | Japan | 5650871 |
293 | Local Institution | Suita | Osaka | Japan | 5648565 |
294 | Local Institution | Hidaka | Saitama | Japan | 858+6 |
295 | Local Institution | Shimotsuke-shi | Tochigi | Japan | 3290498 |
296 | Local Institution | Bunkyo-ku | Tokyo | Japan | 113-8603 |
297 | Local Institution | Hachioji | Tokyo | Japan | 192-0032 |
298 | Local Institution | Meguro-ku | Tokyo | Japan | 1528902 |
299 | Local Institution | Minato-ku | Tokyo | Japan | 1058471 |
300 | Local Institution | Minato-ku | Tokyo | Japan | 108-0073 |
301 | Local Institution | Mitaka-shi | Tokyo | Japan | 181-8611 |
302 | Local Institution - 0298 | Shinagawa-ku | Tokyo | Japan | 141-8625 |
303 | Local Institution | Shinjuku-Ku | Tokyo | Japan | 1608582 |
304 | Local Institution | Tachikawa-shi | Tokyo | Japan | 1900014 |
305 | Local Institution | Shimonoseki-Shi | Yamaguchi | Japan | 752-8510 |
306 | Local Institution | Fukuoka | Japan | 810-0001 | |
307 | Local Institution | Fukuoka | Japan | 810-8563 | |
308 | Local Institution | Kyoto | Japan | 6008558 | |
309 | Local Institution | Osaka | Japan | 533-0024 | |
310 | Local Institution | Osaka | Japan | 540-0006 | |
311 | Local Institution | Osaka | Japan | 558-8558 | |
312 | Local Institution | Saga | Japan | 849-8501 | |
313 | Local Institution - 0094 | Goyang-si | Gyeonggido | Korea, Republic of | 10380 |
314 | Local Institution | Anyang | Korea, Republic of | 431-070 | |
315 | Local Institution | Busan | Korea, Republic of | 49201 | |
316 | Local Institution | Busan | Korea, Republic of | 49241 | |
317 | Local Institution | Daegu | Korea, Republic of | 41944 | |
318 | Local Institution | Daegu | Korea, Republic of | 42415 | |
319 | Local Institution | Daegu | Korea, Republic of | 700-712 | |
320 | Local Institution | Gwangju | Korea, Republic of | 61469 | |
321 | Local Institution | Incheon | Korea, Republic of | 22332 | |
322 | Local Institution | Seongnam-si | Korea, Republic of | 13620 | |
323 | Local Institution | Seoul | Korea, Republic of | 01830 | |
324 | Local Institution | Seoul | Korea, Republic of | 02447 | |
325 | Local Institution | Seoul | Korea, Republic of | 03080 | |
326 | Local Institution | Seoul | Korea, Republic of | 03722 | |
327 | Local Institution | Seoul | Korea, Republic of | 04763 | |
328 | Local Institution | Seoul | Korea, Republic of | 05505 | |
329 | Local Institution | Seoul | Korea, Republic of | 06273 | |
330 | Local Institution | Seoul | Korea, Republic of | 06351 | |
331 | Local Institution | Seoul | Korea, Republic of | 07061 | |
332 | Local Institution | Seoul | Korea, Republic of | 08308 | |
333 | Local Institution | Ciudad de Mexico | Distrito Federal | Mexico | 14080 |
334 | Local Institution | Mexico | Distrito Federal | Mexico | 14269 |
335 | Local Institution | Guadalajara | Jalisco | Mexico | 44670 |
336 | Local Institution | Monterrey | Nuevo LEON | Mexico | 64460 |
337 | Local Institution | Culiacan | Sinaloa | Mexico | 80020 |
338 | Local Institution | Durango | Mexico | 34217 | |
339 | Local Institution | Bergen | Norway | 5021 | |
340 | Local Institution | Grålum | Norway | 1714 | |
341 | Local Institution | Kristiansand | Norway | 4604 | |
342 | Local Institution | Lørenskog | Norway | 1478 | |
343 | Local Institution | Oslo | Norway | 0424 | |
344 | Local Institution | Stavanger | Norway | 4011 | |
345 | Local Institution | Bydgoszcz | Poland | 85-094 | |
346 | Local Institution | Chelm | Poland | 22-100 | |
347 | Local Institution | Gdansk | Poland | 80-803 | |
348 | Local Institution | Grodzisk Mazowieciki | Poland | 05-825 | |
349 | Local Institution | Katowice | Poland | 40-635 | |
350 | Local Institution | Konskie | Poland | 26-200 | |
351 | Local Institution | Lodz | Poland | 93-113 | |
352 | Local Institution | Olsztyn | Poland | 10-561 | |
353 | Local Institution | Sandomierz | Poland | 27-600 | |
354 | Local Institution | Skarzysko-Kamienna | Poland | 26-110 | |
355 | Local Institution | Walcz | Poland | 78-600 | |
356 | Local Institution | Warszawa | Poland | 02-097 | |
357 | Local Institution | Warszawa | Poland | 02-957 | |
358 | Local Institution | Warszawa | Poland | 04-141 | |
359 | Local Institution | Wejherowo | Poland | 84-200 | |
360 | Local Institution | Barnaul | Russian Federation | 656024 | |
361 | Local Institution | Kemerovo | Russian Federation | 650002 | |
362 | Local Institution | Moscow | Russian Federation | 117593 | |
363 | Local Institution | Moscow | Russian Federation | 125367 | |
364 | Local Institution | Novosibirsk | Russian Federation | 630087 | |
365 | Local Institution | Smolensk | Russian Federation | 214018 | |
366 | Local Institution | St. Petersburg | Russian Federation | 194354 | |
367 | Local Institution | Yaroslavl | Russian Federation | 150030 | |
368 | Local Institution - 0372 | León | Castilla Y León | Spain | 24071 |
369 | Local Institution | A Coruna | Spain | 15006 | |
370 | Local Institution | Albacete | Spain | 02006 | |
371 | Local Institution | Badalona | Spain | 8916 | |
372 | Local Institution | Barcelona | Spain | 08003 | |
373 | Local Institution | Barcelona | Spain | 08035 | |
374 | Local Institution | Barcelona | Spain | 08036 | |
375 | Local Institution | Córdoba | Spain | 14004 | |
376 | Local Institution | Girona | Spain | 17007 | |
377 | Local Institution | L'Hospitalet de Llobregat | Spain | 08907 | |
378 | Local Institution | Lleida | Spain | 25008 | |
379 | Local Institution | Madrid | Spain | 28007 | |
380 | Local Institution | Madrid | Spain | 28034 | |
381 | Local Institution | Madrid | Spain | 28041 | |
382 | Local Institution | Madrid | Spain | 28046 | |
383 | Local Institution | Sabadell, Barcelona | Spain | 08208 | |
384 | Local Institution | San Sebastian | Spain | 20014 | |
385 | Local Institution | Sant Joan Despi | Spain | 08970 | |
386 | Local Institution | Santiago de Compostela | Spain | 15706 | |
387 | Local Institution | Sevilla | Spain | 41009 | |
388 | Local Institution | Sevilla | Spain | 41013 | |
389 | Local Institution | Tarragona | Spain | 43005 | |
390 | Local Institution | Terrassa | Spain | 08222 | |
391 | Local Institution | Valencia | Spain | 46026 | |
392 | Local Institution | Valladolid | Spain | 47005 | |
393 | Local Institution | Vigo | Spain | 36312 | |
394 | Local Institution - 0128 | Malmö | Skane Lan | Sweden | SE-205 02 |
395 | Local Institution | Göteborg | Sweden | SE-43146 | |
396 | Local Institution | Hassleholm | Sweden | 28125 | |
397 | Local Institution | Umea | Sweden | 901 87 | |
398 | Local Institution | Uppsala | Sweden | 751 85 | |
399 | Local Institution | Aarau | Switzerland | 5001 | |
400 | Local Institution | Basel | Switzerland | 4031 | |
401 | Local Institution | Bern | Switzerland | 3010 | |
402 | Local Institution | Geneve | Switzerland | 1205 | |
403 | Local Institution | Lausanne | Switzerland | 1011 | |
404 | Local Institution | Zurich | Switzerland | 8032 | |
405 | Local Institution | Canterbury | Kent | United Kingdom | CT1 3NG |
406 | Local Institution | Aberdeen | United Kingdom | AB25 2ZD | |
407 | Local Institution | Ashford | United Kingdom | TN24 0LZ | |
408 | Local Institution | Bath | United Kingdom | BA1 3NG | |
409 | Local Institution | Chester | United Kingdom | CH2 1UL | |
410 | Local Institution | Edinburgh | United Kingdom | EH16 4SA | |
411 | Local Institution | Glasgow | United Kingdom | G51 4TF | |
412 | Local Institution | Lancashire | United Kingdom | BL9 7TD | |
413 | Local Institution | London | United Kingdom | SE5 9RF | |
414 | Local Institution | London | United Kingdom | W1T 7HA | |
415 | Local Institution | Luton | United Kingdom | LU4 0DZ | |
416 | Local Institution | Manchester | United Kingdom | M6 8HD | |
417 | Local Institution | Nottingham | United Kingdom | NG5 1PB | |
418 | Local Institution | Sheffield | United Kingdom | S10 2JF | |
419 | Local Institution | Staffordshire | United Kingdom | ST4 6QG |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Janssen, LP
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- CV010-031