VICTORION-2P: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05030428
Collaborator
(none)
15,000
474
2
70.6
31.6
0.4
Study Details
Study Description
Brief Summary
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
15000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, double-blind, parallel group, placebo-controlled, multi-center, event-driven studyrandomized, double-blind, parallel group, placebo-controlled, multi-center, event-driven study
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
Actual Study Start Date
:
Nov 23, 2021
Anticipated Primary Completion Date
:
Oct 13, 2027
Anticipated Study Completion Date
:
Oct 13, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inclisiran sodium Subcutaneous injection |
Drug: Inclisiran sodium 300 mg
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
|
| Placebo Comparator: Placebo Subcutaneous injection |
Drug: Placebo
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
|
Outcome Measures
Primary Outcome Measures
- Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) [From randomization to total follow-up time (up to 72 months)]
3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
Secondary Outcome Measures
- Time to Occurrence of Cardiovascular (CV) Death [From randomization to total follow-up time (up to 72 months)]
CV death is defined as death due to cardiovascular events
- Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events) [From randomization to total follow-up time (up to 72 months)]
A composite 4P- MACE is defined as CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization.
- Time to occurrence of all-cause death [From randomization to total follow-up time (up to 72 months)]
All-Cause death is defined as: all deaths from randomization until up to 72 months
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Fasting LDL-C ≥ 70 mg/dL at randomization visit
-
Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
-
Established CV disease defined as ANY of the following three conditions
-
Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
-
History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
-
Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.
Exclusion Criteria:
-
Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit
-
Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
-
Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary re-vascularization within the 6 months after the first study visit
-
Heart failure NYHA class III or IV
-
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
-
Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
-
Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
-
History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
-
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group Llc | Anniston | Alabama | United States | 36207 |
| 2 | Eastern Shore Research Group, LLC | Fairhope | Alabama | United States | 36532 |
| 3 | Alaska Cardiology Reserach Foundation, NFP | Anchorage | Alaska | United States | 99508 |
| 4 | Elite Clinical Studies | Phoenix | Arizona | United States | 85018 |
| 5 | Clinical Research Inst of Arizona | Sun City West | Arizona | United States | 85375 |
| 6 | Novartis Investigative Site | Little Rock | Arkansas | United States | 72205 |
| 7 | Central Cardiology Medical Center | Bakersfield | California | United States | 93308 |
| 8 | John Muir Physician Network Clinical Research Center | Concord | California | United States | 94520 |
| 9 | The Heart Group Cardiovascular Associates Inc | Fresno | California | United States | 93720 |
| 10 | Diabetes/Lipid Management Center | Huntington Beach | California | United States | 92648 |
| 11 | American Institute of Research | Los Angeles | California | United States | 90017 |
| 12 | Cabrillo Cardiology Medical Group | Oxnard | California | United States | 93030 |
| 13 | Novartis Investigative Site | San Ramon | California | United States | 94582 |
| 14 | Helping Hands Medical Associates, INC | Santa Ana | California | United States | 92704 |
| 15 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
| 16 | Manshadi Heart Institute | Stockton | California | United States | 95204 |
| 17 | Novartis Investigative Site | Torrance | California | United States | 90502 |
| 18 | Blue Coast Research Center LLC | Vista | California | United States | 92083 |
| 19 | Interventional Cardiology Medical Group | West Hills | California | United States | 91307 |
| 20 | d-b-a Greenwich Cardio Assoc | Greenwich | Connecticut | United States | 06830 |
| 21 | Chase Medical Research, LLC | Waterbury | Connecticut | United States | 06708 |
| 22 | Novartis Investigative Site | Washington | District of Columbia | United States | 20010 |
| 23 | Emerson Clinical Research Institute, LLC | Washington | District of Columbia | United States | 20020 |
| 24 | Excel Medical Clinical Trials LLC | Boca Raton | Florida | United States | 33434 |
| 25 | Cardiovascular and Vein Center of Florida | Bradenton | Florida | United States | 34209 |
| 26 | Cardiology Research Associates | Daytona Beach | Florida | United States | 32117 |
| 27 | National Research Institute | Hialeah | Florida | United States | 33013 |
| 28 | Cano Research | Hollywood | Florida | United States | 33024 |
| 29 | Infinite Clinical Research | Miami | Florida | United States | 33133 |
| 30 | Advanced Research for Health Improvement LLC | Naples | Florida | United States | 34102 |
| 31 | SEC Clinical Research | Pensacola | Florida | United States | 32501 |
| 32 | Peace River Cardiovascular Center | Port Charlotte | Florida | United States | 33952 |
| 33 | Advanced Medical Research Center | Saint Petersburg | Florida | United States | 33713 |
| 34 | Genesis Clinical Research | Tampa | Florida | United States | 33614 |
| 35 | Ravessa Clinical Research | Tampa | Florida | United States | 33880 |
| 36 | Cardiology Partners Clinical Research Institute | Wellington | Florida | United States | 33449 |
| 37 | Novartis Investigative Site | Wellington | Florida | United States | 33449 |
| 38 | Novartis Investigative Site | Cumming | Georgia | United States | 30041 |
| 39 | APRC, Inc | Dunwoody | Georgia | United States | 30338 |
| 40 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
| 41 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 42 | Saltzer Health | Nampa | Idaho | United States | 83686 |
| 43 | Biofortis Research | Addison | Illinois | United States | 60101 |
| 44 | Northwest Heart Clinical Research LLC | Arlington Heights | Illinois | United States | 60005 |
| 45 | Chicago Clinical Research Institute Inc | Chicago | Illinois | United States | 60607 |
| 46 | Novartis Investigative Site | Chicago | Illinois | United States | 60607 |
| 47 | Novartis Investigative Site | Oakbrook Terrace | Illinois | United States | 60181 |
| 48 | Novartis Investigative Site | Peoria | Illinois | United States | 61603 |
| 49 | Novartis Investigative Site | Elkhart | Indiana | United States | 46514 |
| 50 | Witham Health Services | Lebanon | Indiana | United States | 46052 |
| 51 | Cardiovascular Research Of Northwest Indiana, Llc | Munster | Indiana | United States | 46321 |
| 52 | Novartis Investigative Site | Overland Park | Kansas | United States | 66209 |
| 53 | Cambridge Medical Trials | Alexandria | Louisiana | United States | 71301 |
| 54 | Grace Research LLC | Bossier City | Louisiana | United States | 71111 |
| 55 | Cardiovascular Associates Research Main Center | Covington | Louisiana | United States | 70433 |
| 56 | Clinical Trials Management, LLC Clinical Trials Mgmt-Covington | Covington | Louisiana | United States | 70433 |
| 57 | Avant Research Associates LLC | Crowley | Louisiana | United States | 70526 |
| 58 | Horizon Research Group of Opelousas, LLC | Eunice | Louisiana | United States | 70535 |
| 59 | Louisiana Heart Center Research | Hammond | Louisiana | United States | 70403 |
| 60 | Cardiovascular Institute of the South Dept of Cardiovascular Inst | Houma | Louisiana | United States | 70360 |
| 61 | Cardiovascular Institute of the South | Lafayette | Louisiana | United States | 70506 |
| 62 | Novartis Investigative Site | Mandeville | Louisiana | United States | 70471 |
| 63 | Crescent City Clinical Research Center | Metairie | Louisiana | United States | 70006 |
| 64 | Clinical Trials of America LA LLC | Monroe | Louisiana | United States | 71201 |
| 65 | Barnum Medical Research Inc | Natchitoches | Louisiana | United States | 71457 |
| 66 | Cardiovascular Institute of the South | Opelousas | Louisiana | United States | 70570 |
| 67 | Novartis Investigative Site | Shreveport | Louisiana | United States | 71101 |
| 68 | Louisiana Heart Center Research | Slidell | Louisiana | United States | 70458 |
| 69 | Southern Clinical Research | Zachary | Louisiana | United States | 70791 |
| 70 | Metropolitan Cardiovascular Consultants LLC | Beltsville | Maryland | United States | 20705 |
| 71 | Anderson Medical Research Main Center | Fort Washington | Maryland | United States | 20744 |
| 72 | Novartis Investigative Site | Glenn Dale | Maryland | United States | 20769 |
| 73 | Novartis Investigative Site | Rockville | Maryland | United States | 20850 |
| 74 | Tidal Health Peninsula Regional Inc | Salisbury | Maryland | United States | 21804 |
| 75 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 76 | AA Medical Research Center | Flint | Michigan | United States | 48504 |
| 77 | Healthy Heart Cardiology | Grand Rapids | Michigan | United States | 49546 |
| 78 | MidMichigan Medical Center Midland Main Center | Midland | Michigan | United States | 48640 |
| 79 | Traverse Heart and Vascular | Traverse City | Michigan | United States | 49684 |
| 80 | Metro Health Univ of MI Health Metro Health U Of Mi Health | Wyoming | Michigan | United States | 49519 |
| 81 | St. Joseph Mercy Health System | Ypsilanti | Michigan | United States | 48197 |
| 82 | Novartis Investigative Site | Robbinsdale | Minnesota | United States | 55422 |
| 83 | Novartis Investigative Site | Saint Cloud | Minnesota | United States | 56303 |
| 84 | Belzoni Clinical Research | Belzoni | Mississippi | United States | 39038 |
| 85 | Jackson Heart Clinic | Jackson | Mississippi | United States | 39216 |
| 86 | Cardiology Associates of North MS | Tupelo | Mississippi | United States | 38801 |
| 87 | Yazoo Clinical Research | Yazoo City | Mississippi | United States | 39194 |
| 88 | Physician Research Collaboration | Lincoln | Nebraska | United States | 68516 |
| 89 | Novartis Investigative Site | Omaha | Nebraska | United States | 68114 |
| 90 | AB Clinical Trials | Las Vegas | Nevada | United States | 89119 |
| 91 | Monmouth Cardiology Associates | Eatontown | New Jersey | United States | 07724 |
| 92 | New Jersey Heart | Linden | New Jersey | United States | 07036 |
| 93 | Novartis Investigative Site | Manalapan | New Jersey | United States | 07726 |
| 94 | Meridian Clinical Research | Binghamton | New York | United States | 13901 |
| 95 | Novartis Investigative Site | Endwell | New York | United States | 13760 |
| 96 | North Shore Diabetes and Endocrine Associates | New Hyde Park | New York | United States | 11042 |
| 97 | Rochester Clinical Research | Rochester | New York | United States | 14609 |
| 98 | Novartis Investigative Site | Charlotte | North Carolina | United States | 28277 |
| 99 | Lucas Research | Morehead City | North Carolina | United States | 28557 |
| 100 | Novartis Investigative Site | Winston-Salem | North Carolina | United States | 27157 |
| 101 | Wake Forest U of Health Sciences-Cardiology Dept | Winston-Salem | North Carolina | United States | 27157 |
| 102 | Novartis Investigative Site | Grand Forks | North Dakota | United States | 58201 |
| 103 | Meridian Clinical Research | Cincinnati | Ohio | United States | 45246 |
| 104 | University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland | Cleveland | Ohio | United States | 44106-5028 |
| 105 | Novartis Investigative Site | Kettering | Ohio | United States | 45429 |
| 106 | Rama Research, LLC | Marion | Ohio | United States | 43302 |
| 107 | Novartis Investigative Site | Corvallis | Oregon | United States | 97330 |
| 108 | Novartis Investigative Site | Pittsburgh | Pennsylvania | United States | 15236 |
| 109 | Novartis Investigative Site | Uniontown | Pennsylvania | United States | 15401 |
| 110 | Upstate Cardiology | Greenville | South Carolina | United States | 29607 |
| 111 | Family Medicine of Sayebrook | Myrtle Beach | South Carolina | United States | 29588 |
| 112 | Apex Cardiology Research Associates of Jackson | Jackson | Tennessee | United States | 38301 |
| 113 | Novartis Investigative Site | Knoxville | Tennessee | United States | 37917 |
| 114 | Tennessee Center for Clinical Trials | Tullahoma | Tennessee | United States | 37388 |
| 115 | PharmaTex Research LLC | Amarillo | Texas | United States | 79106-4165 |
| 116 | Novartis Investigative Site | Bedford | Texas | United States | 76021 |
| 117 | Novartis Investigative Site | Dallas | Texas | United States | 75226 |
| 118 | Novartis Investigative Site | Dallas | Texas | United States | 75231 |
| 119 | Southwest Family Medicine Associates | Dallas | Texas | United States | 75235 |
| 120 | Novartis Investigative Site | Fort Worth | Texas | United States | 76104 |
| 121 | Novartis Investigative Site | Fort Worth | Texas | United States | 76107 |
| 122 | East Texas Research Associates Inc. | Livingston | Texas | United States | 77351 |
| 123 | Discovery Clinical Trials | McAllen | Texas | United States | 78503 |
| 124 | Novartis Investigative Site | McAllen | Texas | United States | 78503 |
| 125 | Novartis Investigative Site | Pflugerville | Texas | United States | 78660-3015 |
| 126 | Novartis Investigative Site | San Antonio | Texas | United States | 78229 |
| 127 | Novartis Investigative Site | San Marcos | Texas | United States | 78666 |
| 128 | Novartis Investigative Site | Stephenville | Texas | United States | 76401 |
| 129 | Novartis Investigative Site | Sugar Land | Texas | United States | 77478 |
| 130 | Novartis Investigative Site | The Woodlands | Texas | United States | 77382 |
| 131 | Progressive Clinical Research | Bountiful | Utah | United States | 84010 |
| 132 | Heart Care Associates, P.C. | Hopewell | Virginia | United States | 23860 |
| 133 | York Clinical Research | Norfolk | Virginia | United States | 23510 |
| 134 | Dominion Medical Associates | Richmond | Virginia | United States | 23219 |
| 135 | Roanoke Heart Institute | Roanoke | Virginia | United States | 24014 |
| 136 | Novartis Investigative Site | Seattle | Washington | United States | 98195 |
| 137 | Universal Research Group LLC Suite 202 | Tacoma | Washington | United States | 98405 |
| 138 | Novartis Investigative Site | Wenatchee | Washington | United States | 98801 |
| 139 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1056ABJ |
| 140 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1187 |
| 141 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1405BCH |
| 142 | Novartis Investigative Site | Ciudad Autonoma de Bs As | Buenos Aires | Argentina | C1119ACN |
| 143 | Novartis Investigative Site | Tucuman | San Miguel De Tucuman | Argentina | T4000ICL |
| 144 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S200CVD |
| 145 | Novartis Investigative Site | San Miguel de Tucuman | Tucuman | Argentina | T4000IFL |
| 146 | Novartis Investigative Site | Buenos Aires | Argentina | C1012AAR | |
| 147 | Novartis Investigative Site | Buenos Aires | Argentina | C1430EGF | |
| 148 | Novartis Investigative Site | Cordoba | Argentina | X5016KET | |
| 149 | Novartis Investigative Site | Corrientes | Argentina | W3400 | |
| 150 | Novartis Investigative Site | Formosa | Argentina | P3600 | |
| 151 | Novartis Investigative Site | Santa Fe | Argentina | S3000FWO | |
| 152 | Novartis Investigative Site | Brasschaat | Belgium | 2930 | |
| 153 | Novartis Investigative Site | Genk | Belgium | 3600 | |
| 154 | Novartis Investigative Site | Gent | Belgium | 9000 | |
| 155 | Novartis Investigative Site | Kortrijk | Belgium | 8500 | |
| 156 | Novartis Investigative Site | Sao Jose do Rio Preto | SP | Brazil | 15090-000 |
| 157 | Novartis Investigative Site | Sofia | Bulgaria | 1510 | |
| 158 | Novartis Investigative Site | Edmonton | Alberta | Canada | T6K 4C1 |
| 159 | Novartis Investigative Site | North Vancouver | British Columbia | Canada | V7M 2H4 |
| 160 | Novartis Investigative Site | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 161 | Novartis Investigative Site | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 162 | Novartis Investigative Site | Victoria | British Columbia | Canada | V8R4R2 |
| 163 | Novartis Investigative Site | Victoria | British Columbia | Canada | V8T 5G4 |
| 164 | Novartis Investigative Site | Victoria | British Columbia | Canada | V8V 4A1 |
| 165 | Novartis Investigative Site | Winnipeg | Manitoba | Canada | R3C 0N2 |
| 166 | Novartis Investigative Site | Winnipeg | Manitoba | Canada | R3L 1Z5 |
| 167 | Novartis Investigative Site | Moncton | New Brunswick | Canada | E1G 1A7 |
| 168 | Novartis Investigative Site | Halifax | Nova Scotia | Canada | B3H 3A7 |
| 169 | Novartis Investigative Site | Cambridge | Ontario | Canada | N1R 7R1 |
| 170 | Novartis Investigative Site | Guelph | Ontario | Canada | N1H 1B1 |
| 171 | Novartis Investigative Site | Oakville | Ontario | Canada | L6K 3W7 |
| 172 | Novartis Investigative Site | Peterborough | Ontario | Canada | K9J 0B2 |
| 173 | Novartis Investigative Site | Sarnia | Ontario | Canada | N7T 4X3 |
| 174 | Novartis Investigative Site | Scarborough | Ontario | Canada | M1B 5N1 |
| 175 | Novartis Investigative Site | Stoufville | Ontario | Canada | L4A 1H2 |
| 176 | Novartis Investigative Site | Greenfield Park | Quebec | Canada | J4V 2G8 |
| 177 | Novartis Investigative Site | Montreal | Quebec | Canada | H2X 0A9 |
| 178 | Novartis Investigative Site | Montreal | Quebec | Canada | H4A 3J1 |
| 179 | Novartis Investigative Site | Montreal | Quebec | Canada | H4A 3T2 |
| 180 | Novartis Investigative Site | Montreal | Quebec | Canada | H4N 2W2 |
| 181 | Novartis Investigative Site | Sainte Foy | Quebec | Canada | G1V 4G2 |
| 182 | Novartis Investigative Site | Sainte Foy | Quebec | Canada | G1V 4G5 |
| 183 | Novartis Investigative Site | Trois Rivieres | Quebec | Canada | G8Z 3R9 |
| 184 | Novartis Investigative Site | Quebec | Canada | G1W 4R4 | |
| 185 | Novartis Investigative Site | Quebec | Canada | G2J 0C4 | |
| 186 | Novartis Investigative Site | Temuco | Region De La Araucania | Chile | 4780000 |
| 187 | Novartis Investigative Site | Santiago | RM | Chile | 8380465 |
| 188 | Novartis Investigative Site | Vina Del Mar | Valparaiso | Chile | 2520997 |
| 189 | Novartis Investigative Site | Santiago | Chile | 7500710 | |
| 190 | Novartis Investigative Site | Santiago | Chile | 8207257 | |
| 191 | Novartis Investigative Site | Santiago | Chile | ||
| 192 | Novartis Investigative Site | Chongqing | Chongqing | China | 400016 |
| 193 | Novartis Investigative Site | Guangzhou City | Guangdong | China | 510000 |
| 194 | Novartis Investigative Site | Guangzhou | Guangdong | China | 51000 |
| 195 | Novartis Investigative Site | Guangzhou | Guangdong | China | 510515 |
| 196 | Novartis Investigative Site | Wuhan | Hubei | China | 430022 |
| 197 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210009 |
| 198 | Novartis Investigative Site | Nanjing | Jiangsu | China | 211166 |
| 199 | Novartis Investigative Site | Xuzhou | Jiangsu | China | 221003 |
| 200 | Novartis Investigative Site | Jinan | Shandong | China | 250013 |
| 201 | Novartis Investigative Site | Chengdu | Sichuan | China | 610041 |
| 202 | Novartis Investigative Site | Urumqi | Xinjiang | China | 830001 |
| 203 | Novartis Investigative Site | Beijing | China | 100029 | |
| 204 | Novartis Investigative Site | Beijing | China | 100034 | |
| 205 | Novartis Investigative Site | Beijing | China | 100191 | |
| 206 | Novartis Investigative Site | Jinan | China | 250012 | |
| 207 | Novartis Investigative Site | Tianjin | China | ||
| 208 | Novartis Investigative Site | Krapinske toplice | Croatia | 49 217 | |
| 209 | Novartis Investigative Site | Opatija | Croatia | 51410 | |
| 210 | Novartis Investigative Site | Rijeka | Croatia | 51000 | |
| 211 | Novartis Investigative Site | Slavonski Brod | Croatia | 35000 | |
| 212 | Novartis Investigative Site | Zagreb | Croatia | 10000 | |
| 213 | Novartis Investigative Site | Louny | Czech Republic | Czechia | |
| 214 | Novartis Investigative Site | Policska | CZE | Czechia | 57201 |
| 215 | Novartis Investigative Site | Ostrava | Czechia | 728 80 | |
| 216 | Novartis Investigative Site | Zlin | Czechia | 76001 | |
| 217 | Novartis Investigative Site | Herning | Central Jutland | Denmark | Dk-7400 |
| 218 | Novartis Investigative Site | Arhus C | Denmark | DK 8000 | |
| 219 | Novartis Investigative Site | Viborg | Denmark | DK-8800 | |
| 220 | Novartis Investigative Site | Tallinn | Estonia | 13419 | |
| 221 | Novartis Investigative Site | Tallinn | Estonia | 13619 | |
| 222 | Novartis Investigative Site | Tartu | Estonia | 50406 | |
| 223 | Novartis Investigative Site | Auxerre | France | 89000 | |
| 224 | Novartis Investigative Site | Brest | France | 29200 | |
| 225 | Novartis Investigative Site | Chambray les Tours | France | 37170 | |
| 226 | Novartis Investigative Site | Clermont Ferrand | France | 63000 | |
| 227 | Novartis Investigative Site | Compiègne | France | 60321 | |
| 228 | Novartis Investigative Site | Corbeil Essonnes | France | 91100 | |
| 229 | Novartis Investigative Site | Creteil | France | 94000 | |
| 230 | Novartis Investigative Site | Grenoble Cedex 9 | France | 38043 | |
| 231 | Novartis Investigative Site | Le Coudray | France | 28630 | |
| 232 | Novartis Investigative Site | Lille | France | 59042 | |
| 233 | Novartis Investigative Site | Limoges cedex | France | 87042 | |
| 234 | Novartis Investigative Site | Marseille Cedex 8 | France | 13008 | |
| 235 | Novartis Investigative Site | Montauban | France | 82017 | |
| 236 | Novartis Investigative Site | Montpellier | France | 34295 | |
| 237 | Novartis Investigative Site | Nice | France | 06000 | |
| 238 | Novartis Investigative Site | Nimes Cedex 09 | France | 30029 | |
| 239 | Novartis Investigative Site | Orleans | France | 45100 | |
| 240 | Novartis Investigative Site | Paris cedex 18 | France | 75877 | |
| 241 | Novartis Investigative Site | Paris | France | 75010 | |
| 242 | Novartis Investigative Site | Paris | France | 75015 | |
| 243 | Novartis Investigative Site | Paris | France | ||
| 244 | Novartis Investigative Site | Pau Cedex | France | 64046 | |
| 245 | Novartis Investigative Site | Pessac Cedex | France | 33604 | |
| 246 | Novartis Investigative Site | Poitiers | France | 86021 | |
| 247 | Novartis Investigative Site | Reims | France | 51090 | |
| 248 | Novartis Investigative Site | Rennes | France | 35043 | |
| 249 | Novartis Investigative Site | Toulouse Cedex | France | 31059 | |
| 250 | Novartis Investigative Site | Tourcoing | France | 59208 | |
| 251 | Novartis Investigative Site | Valenciennes | France | 59300 | |
| 252 | Novartis Investigative Site | Pecs | Baranya | Hungary | H-7624 |
| 253 | Novartis Investigative Site | Oroshaza | Csongrad | Hungary | 5900 |
| 254 | Novartis Investigative Site | Balatonfured | Hungary | 8230 | |
| 255 | Novartis Investigative Site | Budapest | Hungary | 1122 | |
| 256 | Novartis Investigative Site | Budapest | Hungary | 1145 | |
| 257 | Novartis Investigative Site | Kecskemet | Hungary | 6001 | |
| 258 | Novartis Investigative Site | Pecs | Hungary | 7623 | |
| 259 | Novartis Investigative Site | Guntur | Andhrapradesh | India | 522001 |
| 260 | Novartis Investigative Site | New Delhi | Delhi | India | 110 060 |
| 261 | Novartis Investigative Site | Ahmedabad | Gujarat | India | 380 060 |
| 262 | Novartis Investigative Site | Ahmedabad | Gujarat | India | 382428 |
| 263 | Novartis Investigative Site | Vadodara | Gujarat | India | 390022 |
| 264 | Novartis Investigative Site | Ahmedabad | Gujrat | India | 380060 |
| 265 | Novartis Investigative Site | Bengaluru | Karnataka | India | 560024 |
| 266 | Novartis Investigative Site | Kochi | Kerala | India | 682 018 |
| 267 | Novartis Investigative Site | Kozhikode | Kerala | India | 673008 |
| 268 | Novartis Investigative Site | Indore | Madhyapradesh | India | 452003 |
| 269 | Novartis Investigative Site | Nagpur | Maharashtra | India | 440012 |
| 270 | Novartis Investigative Site | Nagpur | Maharashtra | India | 440033 |
| 271 | Novartis Investigative Site | Nashik | Maharashtra | India | 422 005 |
| 272 | Novartis Investigative Site | Pune | Maharashtra | India | 411 019 |
| 273 | Novartis Investigative Site | Pune | Maharashtra | India | 411004 |
| 274 | Novartis Investigative Site | Chennai | Tamil Nadu | India | 600081 |
| 275 | Novartis Investigative Site | Coimbatore | Tamil Nadu | India | 641037 |
| 276 | Novartis Investigative Site | Hyderabad | Telangana | India | 500034 |
| 277 | Novartis Investigative Site | Secunderabad | Telangana | India | 500003 |
| 278 | Novartis Investigative Site | Kanpur | Uttar Pradesh | India | 208002 |
| 279 | Novartis Investigative Site | Varanasi | Uttar Pradesh | India | 221010 |
| 280 | Novartis Investigative Site | DehraDun | Uttarakhand | India | 248001 |
| 281 | Novartis Investigative Site | Kolkata | West Bengal | India | 700054 |
| 282 | Novartis Investigative Site | Belagavi | India | 590010 | |
| 283 | Novartis Investigative Site | Zerifin | HaMerkaz | Israel | 7030000 |
| 284 | Novartis Investigative Site | Nahariya | Israel | 22100 | |
| 285 | Novartis Investigative Site | Safed | Israel | 13100 | |
| 286 | Novartis Investigative Site | Tel Giborim, Holon | Israel | 58100 | |
| 287 | Novartis Investigative Site | Bologna | BO | Italy | 40133 |
| 288 | Novartis Investigative Site | Brescia | BS | Italy | 25123 |
| 289 | Novartis Investigative Site | Cona | FE | Italy | 44100 |
| 290 | Novartis Investigative Site | Firenze | FI | Italy | |
| 291 | Novartis Investigative Site | Grosseto | GR | Italy | 58100 |
| 292 | Novartis Investigative Site | Pozzilli | IS | Italy | 86077 |
| 293 | Novartis Investigative Site | Milano | MI | Italy | 20132 |
| 294 | Novartis Investigative Site | Milano | MI | Italy | 20138 |
| 295 | Novartis Investigative Site | Milano | MI | Italy | 20149 |
| 296 | Novartis Investigative Site | Milano | MI | Italy | 20162 |
| 297 | Novartis Investigative Site | Rozzano | MI | Italy | 20089 |
| 298 | Novartis Investigative Site | Modena | MO | Italy | 41126 |
| 299 | Novartis Investigative Site | San Vito al Tagliamento | PN | Italy | 33078 |
| 300 | Novartis Investigative Site | Siena | SI | Italy | 53100 |
| 301 | Novartis Investigative Site | Torino | TO | Italy | 10126 |
| 302 | Novartis Investigative Site | Cona | VE | Italy | 44124 |
| 303 | Novartis Investigative Site | Cheongju si | Chungcheongbuk Do | Korea, Republic of | 28644 |
| 304 | Novartis Investigative Site | Daegu | Dalseo Gu | Korea, Republic of | 42602 |
| 305 | Novartis Investigative Site | Wonju | Gangwon-Do | Korea, Republic of | 26426 |
| 306 | Novartis Investigative Site | Bundang Gu | Gyeonggi Do | Korea, Republic of | 13620 |
| 307 | Novartis Investigative Site | Yangsan Si | Gyeongsangnam Do | Korea, Republic of | 50612 |
| 308 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 02447 |
| 309 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 08308 |
| 310 | Novartis Investigative Site | Busan | Korea, Republic of | 49201 | |
| 311 | Novartis Investigative Site | Daegu | Korea, Republic of | 705703 | |
| 312 | Novartis Investigative Site | Daejeon | Korea, Republic of | 302-241 | |
| 313 | Novartis Investigative Site | Gwangju | Korea, Republic of | 61469 | |
| 314 | Novartis Investigative Site | Incheon | Korea, Republic of | 405 760 | |
| 315 | Novartis Investigative Site | Jinju | Korea, Republic of | 660-702 | |
| 316 | Novartis Investigative Site | Seoul | Korea, Republic of | 03080 | |
| 317 | Novartis Investigative Site | Seoul | Korea, Republic of | 03722 | |
| 318 | Novartis Investigative Site | Seoul | Korea, Republic of | 06351 | |
| 319 | Novartis Investigative Site | Seoul | Korea, Republic of | 156-707 | |
| 320 | Novartis Investigative Site | Riga | LV | Latvia | 1038 |
| 321 | Novartis Investigative Site | Daugavpils | Latvia | LV-5417 | |
| 322 | Novartis Investigative Site | Kuldiga | Latvia | LV-3300 | |
| 323 | Novartis Investigative Site | Riga | Latvia | 1012 | |
| 324 | Novartis Investigative Site | Riga | Latvia | LV 1002 | |
| 325 | Novartis Investigative Site | Valmiera | Latvia | 4201 | |
| 326 | Novartis Investigative Site | Kaunas | Kauno Apskritis | Lithuania | 50161 |
| 327 | Novartis Investigative Site | Kaunas | Kauno Apskritis | Lithuania | LT-50177 |
| 328 | Novartis Investigative Site | Klaipeda | Klaipedos Apskritis | Lithuania | 92288 |
| 329 | Novartis Investigative Site | Siauliai | Siauliu Apskritis | Lithuania | LT-76231 |
| 330 | Novartis Investigative Site | Kaunas | Lithuania | LT-49449 | |
| 331 | Novartis Investigative Site | Kaunas | Lithuania | LT-50009 | |
| 332 | Novartis Investigative Site | Vilnius | Lithuania | LT-08661 | |
| 333 | Novartis Investigative Site | Alor Setar | Kedah | Malaysia | 05460 |
| 334 | Novartis Investigative Site | Kuantan | Pahang | Malaysia | 25100 |
| 335 | Novartis Investigative Site | Ipoh | Perak | Malaysia | 30450 |
| 336 | Novartis Investigative Site | Kuala Lumpur | Selangor Darul Ehsan | Malaysia | 43000 |
| 337 | Novartis Investigative Site | Kuala Lumpur | Malaysia | 59100 | |
| 338 | Novartis Investigative Site | Sneek | The Netherlands | Netherlands | 8601 ZR |
| 339 | Novartis Investigative Site | Alkmaar | Netherlands | 1815 JD | |
| 340 | Novartis Investigative Site | Amersfoort | Netherlands | 3813 TZ | |
| 341 | Novartis Investigative Site | Breda | Netherlands | 4818 CK | |
| 342 | Novartis Investigative Site | Deventer | Netherlands | 7416 SE | |
| 343 | Novartis Investigative Site | Doetinchem | Netherlands | 7009 BL | |
| 344 | Novartis Investigative Site | Gouda | Netherlands | 2803 HH | |
| 345 | Novartis Investigative Site | Groningen | Netherlands | 9713 GZ | |
| 346 | Novartis Investigative Site | Groningen | Netherlands | 9728 NZ | |
| 347 | Novartis Investigative Site | Heemstede | Netherlands | 2102 CW | |
| 348 | Novartis Investigative Site | Leeuwarden | Netherlands | 8934 AD | |
| 349 | Novartis Investigative Site | Leiden | Netherlands | 2300 RC | |
| 350 | Novartis Investigative Site | Leiderdorp | Netherlands | 2353 GA | |
| 351 | Novartis Investigative Site | Meppel | Netherlands | 7943 KA | |
| 352 | Novartis Investigative Site | Nijmegen | Netherlands | 6500 HB | |
| 353 | Novartis Investigative Site | Nijmegen | Netherlands | 6532 SZ | |
| 354 | Novartis Investigative Site | Tiel | Netherlands | 4002 WP | |
| 355 | Novartis Investigative Site | Tilburg | Netherlands | 5042 AD | |
| 356 | Novartis Investigative Site | Venlo | Netherlands | 5912 BL | |
| 357 | Novartis Investigative Site | Iloilo city | Iloilo | Philippines | 5000 |
| 358 | Novartis Investigative Site | San Juan City | Philippines | 1500 | |
| 359 | Novartis Investigative Site | Carnaxide | Lisboa | Portugal | 2799 523 |
| 360 | Novartis Investigative Site | Alcabideche | Portugal | 2755-009 | |
| 361 | Novartis Investigative Site | Almada | Portugal | 2801 951 | |
| 362 | Novartis Investigative Site | Coimbra | Portugal | 3000 075 | |
| 363 | Novartis Investigative Site | Guimaraes | Portugal | 4835 044 | |
| 364 | Novartis Investigative Site | Leiria | Portugal | 2410-187 | |
| 365 | Novartis Investigative Site | Lisboa | Portugal | 1500 650 | |
| 366 | Novartis Investigative Site | Lisboa | Portugal | 1600190 | |
| 367 | Novartis Investigative Site | Matosinhos | Portugal | 4454 513 | |
| 368 | Novartis Investigative Site | Santa Maria da Feira | Portugal | 4520 211 | |
| 369 | Novartis Investigative Site | Vila Nova de Gaia | Portugal | 4434 502 | |
| 370 | Novartis Investigative Site | Vila Real | Portugal | 5000-508 | |
| 371 | Ponce Medical School Foundation Inc Centro Med Episcopal San Lucas | Ponce | Puerto Rico | 00716 | |
| 372 | Research and Cardiovascular Corp | Ponce | Puerto Rico | 00717-1322 | |
| 373 | Barbara Diaz Hernandez Research Inc | San Juan | Puerto Rico | 00926 | |
| 374 | FDI Clinical Research Main center | San Juan | Puerto Rico | 00927 | |
| 375 | Novartis Investigative Site | Ivanovo | Russian Federation | 153012 | |
| 376 | Novartis Investigative Site | Izhevsk | Russian Federation | 426061 | |
| 377 | Novartis Investigative Site | Kemerovo | Russian Federation | 650002 | |
| 378 | Novartis Investigative Site | Moscow | Russian Federation | 117997 | |
| 379 | Novartis Investigative Site | Moscow | Russian Federation | 127473 | |
| 380 | Novartis Investigative Site | Rostov on Don | Russian Federation | 344022 | |
| 381 | Novartis Investigative Site | Ryazan | Russian Federation | 390039 | |
| 382 | Novartis Investigative Site | Saint Petersburg | Russian Federation | 194354 | |
| 383 | Novartis Investigative Site | Saint-Petersburg | Russian Federation | 192283 | |
| 384 | Novartis Investigative Site | Saratov | Russian Federation | 410012 | |
| 385 | Novartis Investigative Site | Sochy | Russian Federation | 354057 | |
| 386 | Novartis Investigative Site | St Petersburg | Russian Federation | 191015 | |
| 387 | Novartis Investigative Site | St Petersburg | Russian Federation | 195197 | |
| 388 | Novartis Investigative Site | Tomsk | Russian Federation | 634012 | |
| 389 | Novartis Investigative Site | Vsevolozhsk | Russian Federation | 188640 | |
| 390 | Novartis Investigative Site | Yaroslavl | Russian Federation | 150047 | |
| 391 | Novartis Investigative Site | Singapore | Singapore | 117549 | |
| 392 | Novartis Investigative Site | Singapore | Singapore | 169609 | |
| 393 | Novartis Investigative Site | Singapore | Singapore | 529889 | |
| 394 | Novartis Investigative Site | Singapore | Singapore | 768828 | |
| 395 | Novartis Investigative Site | Bratislava | Slovak Republic | Slovakia | 851 01 |
| 396 | Novartis Investigative Site | Kosice | Slovak Republic | Slovakia | 040 22 |
| 397 | Novartis Investigative Site | Nitra | Slovak Republic | Slovakia | 949 01 |
| 398 | Novartis Investigative Site | Banska Bystrica | SVK | Slovakia | 974 01 |
| 399 | Novartis Investigative Site | Zilina | Zilinsky Kraj | Slovakia | 010 01 |
| 400 | Novartis Investigative Site | Bardejov | Slovakia | 085 01 | |
| 401 | Novartis Investigative Site | Bardejov | Slovakia | 08501 | |
| 402 | Novartis Investigative Site | Bratislava | Slovakia | 83106 | |
| 403 | Novartis Investigative Site | Bratislava | Slovakia | 833 48 | |
| 404 | Novartis Investigative Site | Bratislava | Slovakia | 841 07 | |
| 405 | Novartis Investigative Site | Bratislava | Slovakia | 85101 | |
| 406 | Novartis Investigative Site | Kosice | Slovakia | 040 01 | |
| 407 | Novartis Investigative Site | Lucenec | Slovakia | 98439 | |
| 408 | Novartis Investigative Site | Moldava nad Bodvou | Slovakia | 04501 | |
| 409 | Novartis Investigative Site | Nitra | Slovakia | 949 01 | |
| 410 | Novartis Investigative Site | Nove Zamky | Slovakia | 940 01 | |
| 411 | Novartis Investigative Site | Piestany | Slovakia | 921 01 | |
| 412 | Novartis Investigative Site | Povazska Bystrica | Slovakia | 01701 | |
| 413 | Novartis Investigative Site | Presov | Slovakia | 080 01 | |
| 414 | Novartis Investigative Site | Roznava | Slovakia | 048 01 | |
| 415 | Novartis Investigative Site | Celje | Slovenia | 3000 | |
| 416 | Novartis Investigative Site | Bloemfontein | Free State | South Africa | 9301 |
| 417 | Novartis Investigative Site | Germiston | Gauteng | South Africa | 1401 |
| 418 | Novartis Investigative Site | Cape Town | ZAF | South Africa | 7570 |
| 419 | Novartis Investigative Site | Cape Town | South Africa | 7500 | |
| 420 | Novartis Investigative Site | Cape Town | South Africa | 7531 | |
| 421 | Novartis Investigative Site | Midrand | South Africa | 1685 | |
| 422 | Novartis Investigative Site | Ferrol | A Coruna | Spain | 15405 |
| 423 | Novartis Investigative Site | Almeria | Andalucia | Spain | 04009 |
| 424 | Novartis Investigative Site | Cordoba | Andalucia | Spain | 14004 |
| 425 | Novartis Investigative Site | Jerez de la Frontera | Andalucia | Spain | 11407 |
| 426 | Novartis Investigative Site | Malaga | Andalucia | Spain | 29010 |
| 427 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41009 |
| 428 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41013 |
| 429 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41014 |
| 430 | Novartis Investigative Site | Utrera | Andalucia | Spain | 41710 |
| 431 | Novartis Investigative Site | El Prat de Llobregat | Barcelona | Spain | 08820 |
| 432 | Novartis Investigative Site | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 433 | Novartis Investigative Site | Sabadell | Barcelona | Spain | 08208 |
| 434 | Novartis Investigative Site | Sant Joan Despi | Barcelona | Spain | 08970 |
| 435 | Novartis Investigative Site | Villamartin | Cadiz | Spain | 11650 |
| 436 | Novartis Investigative Site | Santander | Cantabria | Spain | 39008 |
| 437 | Novartis Investigative Site | Salamanca | Castilla Y Leon | Spain | 37007 |
| 438 | Novartis Investigative Site | Valladolid | Castilla Y Leon | Spain | 47011 |
| 439 | Novartis Investigative Site | Reus | Cataluna | Spain | 43201 |
| 440 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08035 |
| 441 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08036 |
| 442 | Novartis Investigative Site | Barcelona | Cataluña | Spain | 08024 |
| 443 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46014 |
| 444 | Novartis Investigative Site | A Coruna | Galicia | Spain | 15006 |
| 445 | Novartis Investigative Site | La Coruna | Galicia | Spain | 15006 |
| 446 | Novartis Investigative Site | Santiago de Compostela | Galicia | Spain | 15706 |
| 447 | Novartis Investigative Site | Alcorcon | Madrid | Spain | 28922 |
| 448 | Novartis Investigative Site | San Sebastian de los Reyes | Madrid | Spain | 28702 |
| 449 | Novartis Investigative Site | El Palmar | Murcia | Spain | 30120 |
| 450 | Novartis Investigative Site | Bilbao | Pais Vasco | Spain | 48013 |
| 451 | Novartis Investigative Site | Vigo | Pontevedra | Spain | 36212 |
| 452 | Novartis Investigative Site | A Coruna | Spain | 15001 | |
| 453 | Novartis Investigative Site | Barcelona | Spain | 08020 | |
| 454 | Novartis Investigative Site | Barcelona | Spain | 08025 | |
| 455 | Novartis Investigative Site | Barcelona | Spain | 08041 | |
| 456 | Novartis Investigative Site | Granada | Spain | 18016 | |
| 457 | Novartis Investigative Site | Huelva | Spain | 21007 | |
| 458 | Novartis Investigative Site | Las Palmas de Gran Canaria | Spain | 35010 | |
| 459 | Novartis Investigative Site | Madrid | Spain | 28006 | |
| 460 | Novartis Investigative Site | Madrid | Spain | 28034 | |
| 461 | Novartis Investigative Site | Madrid | Spain | 28040 | |
| 462 | Novartis Investigative Site | Madrid | Spain | 28041 | |
| 463 | Novartis Investigative Site | Madrid | Spain | 28046 | |
| 464 | Novartis Investigative Site | Zaragoza | Spain | 50009 | |
| 465 | Novartis Investigative Site | Stockholm | SE | Sweden | 141 86 |
| 466 | Novartis Investigative Site | Goteborg | Vastra Gotalands Lan | Sweden | 416 85 |
| 467 | Novartis Investigative Site | Falun | Sweden | 791 82 | |
| 468 | Novartis Investigative Site | Lund | Sweden | 221 85 | |
| 469 | Novartis Investigative Site | Vasteras | Sweden | 721 89 | |
| 470 | Novartis Investigative Site | Kaohsiung | Taiwan | 80756 | |
| 471 | Novartis Investigative Site | Taipei | Taiwan | 10002 | |
| 472 | Novartis Investigative Site | Hat Yai | Songkla | Thailand | 90110 |
| 473 | Novartis Investigative Site | Bangkok | Thailand | 10700 | |
| 474 | Novartis Investigative Site | Chiang Mai | Thailand | 50200 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05030428
Other Study ID Numbers:
- CKJX839B12302
First Posted:
Sep 1, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: