Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Sponsor
Lexicon Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT03521934
Collaborator
Sanofi (Industry)
1,222
466
2
23.8
2.6
0.1
Study Details
Study Description
Brief Summary
Primary Objective:
To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable patients after admission for worsening heart failure (WHF)
Secondary Objectives:
To compare the effects of sotagliflozin to placebo on:
-
The total occurrences of HHF and urgent visit for HF
-
The occurrence of CV death
-
The occurrence of all-cause mortality
-
The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke
-
Change in KCCQ-12 score
-
Change in estimated glomerular filtration rate (eGFR)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The estimated study duration for a given patient will be approximately 3 to 24 months.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure
Actual Study Start Date
:
Jun 11, 2018
Actual Primary Completion Date
:
Jun 5, 2020
Actual Study Completion Date
:
Jun 5, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sotagliflozin Sotagliflozin dose 1, once daily with possible uptitration in the first 8 months to dose 2 |
Drug: Sotagliflozin (SAR439954)
Pharmaceutical form: tablet
Route of administration: oral
|
| Placebo Comparator: Placebo Placebo dose 1, once daily with possible uptitration in the first 8 months to dose 2 |
Drug: Placebo
Pharmaceutical form: tablet
Route of administration: oral
|
Outcome Measures
Primary Outcome Measures
- Total occurrences of CV Death and Heart Failure Events [Baseline through a maximum of 22.3 months]
The primary endpoint is the total occurrences (first and potentially subsequent) of CV death, Hospitalization for Heart Failure (HHF), and urgent HF visits after randomization.
Secondary Outcome Measures
- Total occurrences of Heart Failure Events [Baseline through a maximum of 22.3 months]
Total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization
- Time to CV Death [Baseline through a maximum of 22.3 months]
Time to CV Death after randomization
- Total occurrences of 3-Point MACE plus HHF [Baseline through a maximum of 22.3 months]
Total occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization
- Total occurrences of CV Death, Heart Failure Events, and HF while hospitalized [Baseline through a maximum of 22.3 months]
Total occurrences (first and potentially subsequent) after randomization of CV Death, HHF, urgent HF visits, and HF while hospitalized
- All-Cause Mortality [Baseline through a maximum of 22.3 months]
Time from randomization to all-cause mortality
- Change in Kansas City Cardiomyopathy Questionnaire- 12 (KCCQ-12) Scores [Baseline through a maximum of 22.3 months]
Change in KCCQ12 scores from baseline
- Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) [Baseline through a maximum of 22.3 months]
Change in eGFR (mL/min/1.73m2/year) from baseline to the end of the study
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Type 2 Diabetes Mellitus.
-
Admitted to the hospital, or urgent heart failure visit for worsening heart failure.
-
Prior diagnosis of heart failure (> 3 months).
-
Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days.
-
Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.
-
Brain natriuretic peptide (BNP) ≥150 pg/mL (≥450 pg/mL for patients with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for patients with atrial fibrillation).
-
Patients with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.
-
Signed written informed consent.
Exclusion criteria:
-
Age < 18 years or > 85 years.
-
Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.
-
Cardiac surgery or coronary procedure within 1 month or planned during study.
-
Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
-
Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
-
Acute coronary syndromes within 3 months prior to Randomization.
-
Hemodynamically significant uncorrected primary valvular disease.
-
Significant pulmonary disease contributing substantially to the patient's dyspnea.
-
End stage Heart Failure.
-
History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.
-
History of stroke within 3 months prior to randomization.
-
History of dialysis within 1 year prior to randomization.
-
History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).
-
Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
-
Pregnancy.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number 8400128 | Alexander City | Alabama | United States | 35010 |
| 2 | Investigational Site Number 8400109 | Cottonwood | Arizona | United States | 86326 |
| 3 | Investigational Site Number 8400032 | Little Rock | Arkansas | United States | 72205 |
| 4 | Investigational Site Number 8400080 | Little Rock | Arkansas | United States | 72205 |
| 5 | Investigational Site Number 8400075 | Bakersfield | California | United States | 93309 |
| 6 | Investigational Site Number 8400069 | Fresno | California | United States | 93701 |
| 7 | Investigational Site Number 8400008 | Los Angeles | California | United States | 90024 |
| 8 | Investigational Site Number 8400063 | Los Angeles | California | United States | 90073 |
| 9 | Investigational Site Number 8400127 | National City | California | United States | 91950 |
| 10 | Investigational Site Number 8400007 | Redondo Beach | California | United States | 90277 |
| 11 | Investigational Site Number 8400036 | Stockton | California | United States | 95204 |
| 12 | Investigational Site Number 8400033 | Sylmar | California | United States | 91342 |
| 13 | Investigational Site Number 8400049 | Torrance | California | United States | 90502 |
| 14 | Investigational Site Number 8400028 | Walnut Creek | California | United States | 94598 |
| 15 | Investigational Site Number 8400029 | Bridgeport | Connecticut | United States | 06606 |
| 16 | Investigational Site Number 8400037 | New Haven | Connecticut | United States | 06519 |
| 17 | Investigational Site Number 8400046 | DeLand | Florida | United States | 32720 |
| 18 | Investigational Site Number 8400009 | Gainesville | Florida | United States | 32608 |
| 19 | Investigational Site Number 8400079 | Homestead | Florida | United States | 33033 |
| 20 | Investigational Site Number 8400031 | Jacksonville | Florida | United States | 32207 |
| 21 | Investigational Site Number 8400022 | Jacksonville | Florida | United States | 32216 |
| 22 | Investigational Site Number 8400098 | Lake Mary | Florida | United States | 32746 |
| 23 | Investigational Site Number 8400058 | Miami Beach | Florida | United States | 33140 |
| 24 | Investigational Site Number 8400105 | Orlando | Florida | United States | 32806 |
| 25 | Investigational Site Number 8400082 | Pensacola | Florida | United States | 32504 |
| 26 | Investigational Site Number 8400057 | Port Charlotte | Florida | United States | 33952 |
| 27 | Investigational Site Number 8400006 | Sarasota | Florida | United States | 34239 |
| 28 | Investigational Site Number 8400035 | Tampa | Florida | United States | 33609 |
| 29 | Investigational Site Number 8400042 | Tampa | Florida | United States | 33612 |
| 30 | Investigational Site Number 8400004 | Wellington | Florida | United States | 33449 |
| 31 | Investigational Site Number 8400073 | Atlanta | Georgia | United States | 30322-1020 |
| 32 | Investigational Site Number 8400118 | Tucker | Georgia | United States | 30084 |
| 33 | Investigational Site Number 8400067 | Arlington Heights | Illinois | United States | 60005 |
| 34 | Investigational Site Number 8400043 | Chicago | Illinois | United States | 60637 |
| 35 | Investigational Site Number 8400072 | Elk Grove Village | Illinois | United States | 60007 |
| 36 | Investigational Site Number 8400055 | Indianapolis | Indiana | United States | 46060 |
| 37 | Investigational Site Number 8400020 | Muncie | Indiana | United States | 47303-3400 |
| 38 | Investigational Site Number 8400122 | Richmond | Indiana | United States | 47374 |
| 39 | Investigational Site Number 8400091 | Waterloo | Iowa | United States | 50702 |
| 40 | Investigational Site Number 8400030 | Covington | Louisiana | United States | 70433 |
| 41 | Investigational Site Number 8400065 | Annapolis | Maryland | United States | 21401 |
| 42 | Investigational Site Number 8400012 | Boston | Massachusetts | United States | 02118 |
| 43 | Investigational Site Number 8400001 | Cambridge | Massachusetts | United States | 02135 |
| 44 | Investigational Site Number 8400077 | Detroit | Michigan | United States | 48202 |
| 45 | Investigational Site Number 8400062 | Kalamazoo | Michigan | United States | 49009 |
| 46 | Investigational Site Number 8400017 | Kalamazoo | Michigan | United States | 49048 |
| 47 | Investigational Site Number 8400107 | Duluth | Minnesota | United States | 55805 |
| 48 | Investigational Site Number 8400056 | Jackson | Mississippi | United States | 39216 |
| 49 | Investigational Site Number 8400019 | Columbia | Missouri | United States | 65201 |
| 50 | Investigational Site Number 8400103 | Lee's Summit | Missouri | United States | 64064 |
| 51 | Investigational Site Number 8400132 | Grand Island | Nebraska | United States | 68803 |
| 52 | Investigational Site Number 8400130 | Lincoln | Nebraska | United States | 68506 |
| 53 | Investigational Site Number 8400083 | Omaha | Nebraska | United States | 68124 |
| 54 | Investigational Site Number 8400071 | Omaha | Nebraska | United States | 68198 |
| 55 | Investigational Site Number 8400015 | Ridgewood | New Jersey | United States | 07450-2736 |
| 56 | Investigational Site Number 8400050 | Voorhees | New Jersey | United States | 08043 |
| 57 | Investigational Site Number 8400131 | Albuquerque | New Mexico | United States | 87131 |
| 58 | Investigational Site Number 8400097 | Bronx | New York | United States | 10457 |
| 59 | Investigational Site Number 8400061 | Bronx | New York | United States | 10468-3904 |
| 60 | Investigational Site Number 8400051 | Brooklyn | New York | United States | 11203 |
| 61 | Investigational Site Number 8400111 | Buffalo | New York | United States | 14215 |
| 62 | Investigational Site Number 8400045 | Greensboro | North Carolina | United States | 27401 |
| 63 | Investigational Site Number 8400085 | Raleigh | North Carolina | United States | 27610 |
| 64 | Investigational Site Number 8400078 | Winston-Salem | North Carolina | United States | 27157 |
| 65 | Investigational Site Number 8400087 | Cincinnati | Ohio | United States | 45220 |
| 66 | Investigational Site Number 8400047 | Cincinnati | Ohio | United States | 45267 |
| 67 | Investigational Site Number 8400095 | Maumee | Ohio | United States | 43537 |
| 68 | Investigational Site Number 8400099 | Toledo | Ohio | United States | 43699 |
| 69 | Investigational Site Number 8400121 | Zanesville | Ohio | United States | 43701 |
| 70 | Investigational Site Number 8400054 | Arlington | Oregon | United States | 19001 |
| 71 | Investigational Site Number 8400134 | Doylestown | Pennsylvania | United States | 18901 |
| 72 | Investigational Site Number 8400044 | Natrona Heights | Pennsylvania | United States | 15065 |
| 73 | Investigational Site Number 8400115 | Philadelphia | Pennsylvania | United States | 19104 |
| 74 | Investigational Site Number 8400039 | Sayre | Pennsylvania | United States | 18840 |
| 75 | Investigational Site Number 8400114 | Providence | Rhode Island | United States | 02903 |
| 76 | Investigational Site Number 8400100 | Warwick | Rhode Island | United States | 02886 |
| 77 | Investigational Site Number 8400059 | Charleston | South Carolina | United States | 29425 |
| 78 | Investigational Site Number 8400092 | Columbia | South Carolina | United States | 29203 |
| 79 | Investigational Site Number 8400104 | Greenville | South Carolina | United States | 29605 |
| 80 | Investigational Site Number 8400040 | Rapid City | South Dakota | United States | 57701 |
| 81 | Investigational Site Number 8400088 | Greenville | Tennessee | United States | 30000 |
| 82 | Investigational Site Number 8400089 | Memphis | Tennessee | United States | 38104 |
| 83 | Investigational Site Number 8400053 | Nashville | Tennessee | United States | 37212 |
| 84 | Investigational Site Number 8400041 | Brownsville | Texas | United States | 78521 |
| 85 | Investigational Site Number 8400074 | Dallas | Texas | United States | 75226 |
| 86 | Investigational Site Number 8400016 | Houston | Texas | United States | 77030 |
| 87 | Investigational Site Number 8400123 | McKinney | Texas | United States | 75071 |
| 88 | Investigational Site Number 8400101 | New Braunfels | Texas | United States | 78130 |
| 89 | Investigational Site Number 8400066 | Victoria | Texas | United States | 77901 |
| 90 | Investigational Site Number 8400093 | Manassas | Virginia | United States | 20109 |
| 91 | Investigational Site Number 8400003 | Richmond | Virginia | United States | 23249-0001 |
| 92 | Investigational Site Number 8400126 | Clarksburg | West Virginia | United States | 26301 |
| 93 | Investigational Site Number 8400038 | Morgantown | West Virginia | United States | 26506 |
| 94 | Investigational Site Number 8400048 | Manitowoc | Wisconsin | United States | 54220 |
| 95 | Investigational Site Number 0320031 | Caba | Argentina | 1430 | |
| 96 | Investigational Site Number 0320009 | Caba | Argentina | C1093AAS | |
| 97 | Investigational Site Number 0320016 | Capital Federal | Argentina | 1405 | |
| 98 | Investigational Site Number 0320002 | Ciudad De Buenos Aires | Argentina | C1428DCO | |
| 99 | Investigational Site Number 0320011 | Cordoba | Argentina | X5000AAX | |
| 100 | Investigational Site Number 0320010 | Cordoba | Argentina | X5004BAL | |
| 101 | Investigational Site Number 0320022 | Corrientes | Argentina | 3400 | |
| 102 | Investigational Site Number 0320001 | Corrientes | Argentina | W3400AMZ | |
| 103 | Investigational Site Number 0320024 | Córdoba | Argentina | 5000 | |
| 104 | Investigational Site Number 0320003 | Córdoba | Argentina | X5000JHQ | |
| 105 | Investigational Site Number 0320025 | Córdoba | Argentina | X5006IKK | |
| 106 | Investigational Site Number 0320029 | La Plata | Argentina | B1900AXI | |
| 107 | Investigational Site Number 0320007 | La Plata | Argentina | B1906ESC | |
| 108 | Investigational Site Number 0320006 | Merlo | Argentina | B1722COV | |
| 109 | Investigational Site Number 0320005 | Moron | Argentina | B1708CGU | |
| 110 | Investigational Site Number 0320012 | Olivos | Argentina | 1638 | |
| 111 | Investigational Site Number 0320023 | Quilmes | Argentina | 1878 | |
| 112 | Investigational Site Number 0320018 | Rosario | Argentina | 2000 | |
| 113 | Investigational Site Number 0320013 | Rosario | Argentina | S2000DSR | |
| 114 | Investigational Site Number 0320008 | Salta | Argentina | 4400 | |
| 115 | Investigational Site Number 0320020 | San Martin | Argentina | B1685CSQ | |
| 116 | Investigational Site Number 0320028 | San Miguel De Tucuman | Argentina | T4000IFL | |
| 117 | Investigational Site Number 0320019 | San Miguel De Tucuman | Argentina | T4000NIL | |
| 118 | Investigational Site Number 0320017 | Santa Fe | Argentina | S3000EOZ | |
| 119 | Investigational Site Number 0320015 | Santa Fe | Argentina | S3000FWO | |
| 120 | Investigational Site Number 0320030 | Tucuman | Argentina | T4000JCU | |
| 121 | Investigational Site Number 0320004 | Villa Belgrano | Argentina | X5021FPQ | |
| 122 | Investigational Site Number 0320014 | Villa Maria | Argentina | X5900JKA | |
| 123 | Investigational Site Number 0360007 | Murdoch | Australia | 6150 | |
| 124 | Investigational Site Number 0360001 | Wollongong | Australia | 2500 | |
| 125 | Investigational Site Number 0400006 | Braunau | Austria | 5280 | |
| 126 | Investigational Site Number 0400002 | Feldkirch | Austria | 6800 | |
| 127 | Investigational Site Number 0400007 | Graz | Austria | 8036 | |
| 128 | Investigational Site Number 0400005 | Linz | Austria | 4010 | |
| 129 | Investigational Site Number 0400004 | Salzburg | Austria | 5020 | |
| 130 | Investigational Site Number 0400003 | Wien | Austria | 1090 | |
| 131 | Investigational Site Number 0400001 | Wien | Austria | 1160 | |
| 132 | Investigational Site Number 0560002 | Aalst | Belgium | 9300 | |
| 133 | Investigational Site Number 0560007 | Gent | Belgium | 9000 | |
| 134 | Investigational Site Number 0560004 | Kortrijk | Belgium | 8500 | |
| 135 | Investigational Site Number 0560001 | Leuven | Belgium | 3000 | |
| 136 | Investigational Site Number 0560003 | Liège | Belgium | 4000 | |
| 137 | Investigational Site Number 0560005 | Mol | Belgium | 2400 | |
| 138 | Investigational Site Number 0560006 | Mons | Belgium | 7000 | |
| 139 | Investigational Site Number 0560008 | Roeselare | Belgium | 8800 | |
| 140 | Investigational Site Number 0760009 | Belo Horizonte | Brazil | 30110-908 | |
| 141 | Investigational Site Number 0760024 | Belo Horizonte | Brazil | 30150-221 | |
| 142 | Investigational Site Number 0760002 | Blumenau | Brazil | 89020-430 | |
| 143 | Investigational Site Number 0760011 | Brasilia | Brazil | 70390-903 | |
| 144 | Investigational Site Number 0760005 | Campinas | Brazil | 13060-080 | |
| 145 | Investigational Site Number 0760006 | Campinas | Brazil | 13092-111 | |
| 146 | Investigational Site Number 0760023 | Fortaleza | Brazil | 60840-285 | |
| 147 | Investigational Site Number 0760018 | Goiania | Brazil | 74210050 | |
| 148 | Investigational Site Number 0760010 | Passo Fundo | Brazil | 99010-180 | |
| 149 | Investigational Site Number 0760003 | Porto Alegre | Brazil | 90020-090 | |
| 150 | Investigational Site Number 0760020 | Porto Alegre | Brazil | 90035 003 | |
| 151 | Investigational Site Number 0760021 | Porto Alegre | Brazil | 90610-000 | |
| 152 | Investigational Site Number 0760007 | Porto Alegre | Brazil | 90620-001 | |
| 153 | Investigational Site Number 0760013 | Porto Alegre | Brazil | 91350-250 | |
| 154 | Investigational Site Number 0760004 | Recife | Brazil | 52051-380 | |
| 155 | Investigational Site Number 0760001 | Sao Jose Do Rio Preto | Brazil | 15090-000 | |
| 156 | Investigational Site Number 0760012 | Sao Paulo | Brazil | 04012-909 | |
| 157 | Investigational Site Number 0760008 | Sao Paulo | Brazil | 05403-000 | |
| 158 | Investigational Site Number 0760017 | Votuporanga | Brazil | 15500-003 | |
| 159 | Investigational Site Number 1240013 | Cambridge | Canada | N1R 6V6 | |
| 160 | Investigational Site Number 1240006 | Granby | Canada | J2G 1T7 | |
| 161 | Investigational Site Number 1240015 | Halifax | Canada | B3H 3A7 | |
| 162 | Investigational Site Number 1240002 | Montreal | Canada | H1T 1C8 | |
| 163 | Investigational Site Number 1240019 | Montreal | Canada | H3G 1A4 | |
| 164 | Investigational Site Number 1240018 | Montreal | Canada | H4A 3J1 | |
| 165 | Investigational Site Number 1240004 | Peterborough | Canada | K9J 0B2 | |
| 166 | Investigational Site Number 1240014 | Quebec | Canada | G1V 4G5 | |
| 167 | Investigational Site Number 1240007 | Scarborough | Canada | M1B 4Z8 | |
| 168 | Investigational Site Number 1240005 | Sherbrooke | Canada | J1G 2E8 | |
| 169 | Investigational Site Number 1240011 | Toronto | Canada | M5B 1W8 | |
| 170 | Investigational Site Number 1240001 | Toronto | Canada | M5G 2C4 | |
| 171 | Investigational Site Number 1240009 | Trois-Rivières | Canada | G9A 5C5 | |
| 172 | Investigational Site Number 1520009 | Concepción | Chile | ||
| 173 | Investigational Site Number 1520011 | Santiago | Chile | 80004005 | |
| 174 | Investigational Site Number 1520006 | Santiago | Chile | 8053095 | |
| 175 | Investigational Site Number 1520003 | Santiago | Chile | 8380456 | |
| 176 | Investigational Site Number 1520004 | Santiago | Chile | ||
| 177 | Investigational Site Number 1520005 | Santiago | Chile | ||
| 178 | Investigational Site Number 1520012 | Santiago | Chile | ||
| 179 | Investigational Site Number 1520013 | Santiago | Chile | ||
| 180 | Investigational Site Number 1520002 | Temuco | Chile | ||
| 181 | Investigational Site Number 1520010 | Vina Del Mar | Chile | ||
| 182 | Investigational Site Number 1520001 | Viña Del Mar | Chile | ||
| 183 | Investigational Site Number 2030001 | Brno | Czechia | 62500 | |
| 184 | Investigational Site Number 2030003 | Brno | Czechia | 63600 | |
| 185 | Investigational Site Number 2030004 | Brno | Czechia | 65691 | |
| 186 | Investigational Site Number 2030014 | Kolin 3 | Czechia | 28002 | |
| 187 | Investigational Site Number 2030010 | Kromeriz | Czechia | 76701 | |
| 188 | Investigational Site Number 2030005 | Liberec | Czechia | 46063 | |
| 189 | Investigational Site Number 2030013 | Mestec Kralove | Czechia | 28903 | |
| 190 | Investigational Site Number 2030018 | Praha 10 | Czechia | 10100 | |
| 191 | Investigational Site Number 2030002 | Praha 2 | Czechia | 12808 | |
| 192 | Investigational Site Number 2030007 | Praha 5 - Motol | Czechia | 15006 | |
| 193 | Investigational Site Number 2030017 | Praha 5 | Czechia | 15030 | |
| 194 | Investigational Site Number 2030011 | Prerov | Czechia | 75152 | |
| 195 | Investigational Site Number 2030015 | Pribram I | Czechia | 26101 | |
| 196 | Investigational Site Number 2030006 | Slany | Czechia | 27401 | |
| 197 | Investigational Site Number 2080003 | Aarhus N | Denmark | 8200 | |
| 198 | Investigational Site Number 2080002 | Glostrup | Denmark | 2600 | |
| 199 | Investigational Site Number 2080001 | Herlev | Denmark | 2730 | |
| 200 | Investigational Site Number 2080005 | København Nv | Denmark | 2400 | |
| 201 | Investigational Site Number 2080004 | Ålborg | Denmark | 9100 | |
| 202 | Investigational Site Number 2460004 | Espoo | Finland | 02740 | |
| 203 | Investigational Site Number 2460001 | Helsinki | Finland | 00029 HUS | |
| 204 | Investigational Site Number 2460002 | Jyväskylä | Finland | 40620 | |
| 205 | Investigational Site Number 2460003 | Oulu | Finland | 90220 | |
| 206 | Investigational Site Number 2460005 | Seinäjoki | Finland | 60220 | |
| 207 | Investigational Site Number 2500009 | Chambray Les Tours | France | 37170 | |
| 208 | Investigational Site Number 2500008 | La Tronche | France | 38700 | |
| 209 | Investigational Site Number 2500004 | Le Chesnay | France | 78150 | |
| 210 | Investigational Site Number 2500002 | Le Coudray | France | 28360 | |
| 211 | Investigational Site Number 2500001 | Lille | France | 59037 | |
| 212 | Investigational Site Number 2500007 | Nantes Cedex 1 | France | 44093 | |
| 213 | Investigational Site Number 2500012 | Nice Cedex 1 | France | 06002 | |
| 214 | Investigational Site Number 2500003 | Paris Cedex 18 | France | 75877 | |
| 215 | Investigational Site Number 2500006 | Paris | France | 75015 | |
| 216 | Investigational Site Number 2500005 | Toulouse Cedex 9 | France | 31059 | |
| 217 | Investigational Site Number 2500013 | Vandoeuvre-Les-Nancy Cedex | France | 54511 | |
| 218 | Investigational Site Number 2760020 | Bad Nauheim | Germany | 61231 | |
| 219 | Investigational Site Number 2760016 | Bad Oeynhausen | Germany | 32545 | |
| 220 | Investigational Site Number 2760013 | Berlin | Germany | 12203 | |
| 221 | Investigational Site Number 2760019 | Berlin | Germany | 13347 | |
| 222 | Investigational Site Number 2760001 | Berlin | Germany | 13353 | |
| 223 | Investigational Site Number 2760002 | Berlin | Germany | 13353 | |
| 224 | Investigational Site Number 2760025 | Bielefeld | Germany | 33604 | |
| 225 | Investigational Site Number 2760005 | Bonn | Germany | 53115 | |
| 226 | Investigational Site Number 2760021 | Bremen | Germany | 28277 | |
| 227 | Investigational Site Number 2760035 | Coburg | Germany | 96450 | |
| 228 | Investigational Site Number 2760032 | Dortmund | Germany | 44137 | |
| 229 | Investigational Site Number 2760006 | Dortmund | Germany | 44379 | |
| 230 | Investigational Site Number 2760029 | Erfurt | Germany | 99097 | |
| 231 | Investigational Site Number 2760018 | Essen | Germany | 45138 | |
| 232 | Investigational Site Number 2760033 | Frankfurt Am Main | Germany | 65929 | |
| 233 | Investigational Site Number 2760009 | Greifswald | Germany | 17475 | |
| 234 | Investigational Site Number 2760022 | Heidelberg | Germany | 69115 | |
| 235 | Investigational Site Number 2760031 | Heidelberg | Germany | 69120 | |
| 236 | Investigational Site Number 2760027 | Köln | Germany | 50733 | |
| 237 | Investigational Site Number 2760034 | Lahr | Germany | 77933 | |
| 238 | Investigational Site Number 2760030 | Langen | Germany | 63225 | |
| 239 | Investigational Site Number 2760014 | Leverkusen | Germany | 51375 | |
| 240 | Investigational Site Number 2760036 | Limburg | Germany | 65549 | |
| 241 | Investigational Site Number 2760012 | Ludwigshafen | Germany | 67063 | |
| 242 | Investigational Site Number 2760028 | Merseburg | Germany | 06217 | |
| 243 | Investigational Site Number 2760011 | Rotenburg An Der Fulda | Germany | 36199 | |
| 244 | Investigational Site Number 2760015 | Rüsselsheim | Germany | 65428 | |
| 245 | Investigational Site Number 2760007 | Witten | Germany | 58455 | |
| 246 | Investigational Site Number 2760026 | Würzburg | Germany | 97080 | |
| 247 | Investigational Site Number 3000012 | Athens | Greece | 11526 | |
| 248 | Investigational Site Number 3000004 | Athens | Greece | 11527 | |
| 249 | Investigational Site Number 3000002 | Chalkida | Greece | 34 100 | |
| 250 | Investigational Site Number 3000009 | Elefsina | Greece | 19600 | |
| 251 | Investigational Site Number 3000003 | Haidari | Greece | 12462 | |
| 252 | Investigational Site Number 3000005 | Heraklion | Greece | 71110 | |
| 253 | Investigational Site Number 3000007 | Ioannina | Greece | 455 00 | |
| 254 | Investigational Site Number 3000006 | Larissa | Greece | 41110 | |
| 255 | Investigational Site Number 3000001 | N. Ionia | Greece | 14233 | |
| 256 | Investigational Site Number 3000008 | Thessaloniki | Greece | 546 36 | |
| 257 | Investigational Site Number 3480018 | Berettyóújfalu | Hungary | 4100 | |
| 258 | Investigational Site Number 3480012 | Budapest | Hungary | 1023 | |
| 259 | Investigational Site Number 3480016 | Budapest | Hungary | 1085 | |
| 260 | Investigational Site Number 3480010 | Budapest | Hungary | 1096 | |
| 261 | Investigational Site Number 3480019 | Budapest | Hungary | 1115 | |
| 262 | Investigational Site Number 3480001 | Budapest | Hungary | 1122 | |
| 263 | Investigational Site Number 3480015 | Budapest | Hungary | 1125 | |
| 264 | Investigational Site Number 3480011 | Budapest | Hungary | 1134 | |
| 265 | Investigational Site Number 3480014 | Budapest | Hungary | 1145 | |
| 266 | Investigational Site Number 3480005 | Budapest | Hungary | 1204 | |
| 267 | Investigational Site Number 3480007 | Debrecen | Hungary | 4032 | |
| 268 | Investigational Site Number 3480002 | Dombóvár | Hungary | 7200 | |
| 269 | Investigational Site Number 3480017 | Gyula | Hungary | 5700 | |
| 270 | Investigational Site Number 3480008 | Hódmezövásárhely | Hungary | 6800 | |
| 271 | Investigational Site Number 3480020 | Kistarcsa | Hungary | 2143 | |
| 272 | Investigational Site Number 3480009 | Komárom | Hungary | 2921 | |
| 273 | Investigational Site Number 3480013 | Pécs | Hungary | 7624 | |
| 274 | Investigational Site Number 3480003 | Szekesfehervar | Hungary | 8000 | |
| 275 | Investigational Site Number 3480006 | Zalaegerszeg | Hungary | 8900 | |
| 276 | Investigational Site Number 3760013 | Ashkelon | Israel | 78278 | |
| 277 | Investigational Site Number 3760004 | Hadera | Israel | 38100 | |
| 278 | Investigational Site Number 3760005 | Haifa | Israel | 31096 | |
| 279 | Investigational Site Number 3760006 | Jerusalem | Israel | 91031 | |
| 280 | Investigational Site Number 3760003 | Jerusalem | Israel | 91120 | |
| 281 | Investigational Site Number 3760008 | Jerusalem | Israel | ||
| 282 | Investigational Site Number 3760010 | Nahariya | Israel | 22100 | |
| 283 | Investigational Site Number 3760002 | Petah-Tikva | Israel | 49100 | |
| 284 | Investigational Site Number 3760011 | Rehovot | Israel | 76100 | |
| 285 | Investigational Site Number 3760009 | Safed | Israel | 13100 | |
| 286 | Investigational Site Number 3760001 | Tel Aviv | Israel | 64239 | |
| 287 | Investigational Site Number 3760012 | Tiberias | Israel | 15208 | |
| 288 | Investigational Site Number 3800006 | Arzignano (Vi) | Italy | 36071 | |
| 289 | Investigational Site Number 3800011 | Brescia | Italy | 25123 | |
| 290 | Investigational Site Number 3800017 | Brescia | Italy | 25124 | |
| 291 | Investigational Site Number 3800005 | Cortona | Italy | 52044 | |
| 292 | Investigational Site Number 3800009 | Ferrara | Italy | 44124 | |
| 293 | Investigational Site Number 3800020 | Gallipoli | Italy | 73014 | |
| 294 | Investigational Site Number 3800003 | Legnago | Italy | 37045 | |
| 295 | Investigational Site Number 3800023 | Milano | Italy | 20122 | |
| 296 | Investigational Site Number 3800002 | Milano | Italy | 20138 | |
| 297 | Investigational Site Number 3800012 | Milano | Italy | 20138 | |
| 298 | Investigational Site Number 3800008 | Milano | Italy | 20162 | |
| 299 | Investigational Site Number 3800013 | Monza | Italy | 20052 | |
| 300 | Investigational Site Number 3800022 | Napoli | Italy | 80131 | |
| 301 | Investigational Site Number 3800018 | Pavia | Italy | 27100 | |
| 302 | Investigational Site Number 3800004 | Perugia | Italy | 06132 | |
| 303 | Investigational Site Number 3800016 | Pozzilli | Italy | 86077 | |
| 304 | Investigational Site Number 3800014 | Rimini | Italy | 47900 | |
| 305 | Investigational Site Number 3800010 | Roma | Italy | 00153 | |
| 306 | Investigational Site Number 3800021 | Roma | Italy | 00189 | |
| 307 | Investigational Site Number 3800019 | Scorrano | Italy | 73020 | |
| 308 | Investigational Site Number 3800007 | Udine | Italy | 33100 | |
| 309 | Investigational Site Number 4100008 | Bucheon-Si | Korea, Republic of | 14754 | |
| 310 | Investigational Site Number 4100010 | Busan | Korea, Republic of | 49267 | |
| 311 | Investigational Site Number 4100004 | Daegu | Korea, Republic of | 42472 | |
| 312 | Investigational Site Number 4100001 | Hwaseong-Si | Korea, Republic of | 18450 | |
| 313 | Investigational Site Number 4100003 | Incheon | Korea, Republic of | 22332 | |
| 314 | Investigational Site Number 4100005 | Seongnam-Si | Korea, Republic of | 13620 | |
| 315 | Investigational Site Number 4100002 | Seoul | Korea, Republic of | 03080 | |
| 316 | Investigational Site Number 4100007 | Seoul | Korea, Republic of | 03722 | |
| 317 | Investigational Site Number 4100011 | Seoul | Korea, Republic of | 05030 | |
| 318 | Investigational Site Number 4100009 | Seoul | Korea, Republic of | 06351 | |
| 319 | Investigational Site Number 4280004 | Daugavpils | Latvia | LV-5417 | |
| 320 | Investigational Site Number 4280002 | Liepaja | Latvia | LV-3414 | |
| 321 | Investigational Site Number 4280001 | Riga | Latvia | LV-1002 | |
| 322 | Investigational Site Number 4280003 | Riga | Latvia | LV-1038 | |
| 323 | Investigational Site Number 4400002 | Kaunas | Lithuania | 50161 | |
| 324 | Investigational Site Number 4400005 | Kaunas | Lithuania | 50161 | |
| 325 | Investigational Site Number 4400004 | Klaipeda | Lithuania | LT-92288 | |
| 326 | Investigational Site Number 4400006 | Siauliai | Lithuania | LT-76231 | |
| 327 | Investigational Site Number 4400001 | Vilnius | Lithuania | 08661 | |
| 328 | Investigational Site Number 4400003 | Vilnius | Lithuania | 08661 | |
| 329 | Investigational Site Number 5280003 | Amsterdam | Netherlands | 1034 CS | |
| 330 | Investigational Site Number 5280001 | Breda | Netherlands | 4819 EV | |
| 331 | Investigational Site Number 5280007 | Delft | Netherlands | 2625 AD | |
| 332 | Investigational Site Number 5280002 | Doetinchem | Netherlands | 7009 BL | |
| 333 | Investigational Site Number 5280004 | Hertogenbosch | Netherlands | 5223 GZ 's | |
| 334 | Investigational Site Number 5280006 | Rotterdam | Netherlands | 3045 PM | |
| 335 | Investigational Site Number 5280008 | Sneek | Netherlands | 8601 | |
| 336 | Investigational Site Number 5280005 | Veldhoven | Netherlands | 5504 DB | |
| 337 | Investigational Site Number 5540007 | Auckland | New Zealand | 1023 | |
| 338 | Investigational Site Number 5540006 | Christchurch | New Zealand | 8011 | |
| 339 | Investigational Site Number 5540002 | Hamilton | New Zealand | 3204 | |
| 340 | Investigational Site Number 5540004 | Lower Hutt | New Zealand | ||
| 341 | Investigational Site Number 5540005 | New Plymouth | New Zealand | ||
| 342 | Investigational Site Number 5540003 | Rotorua | New Zealand | 3010 | |
| 343 | Investigational Site Number 6160007 | Bialystok | Poland | 15-276 | |
| 344 | Investigational Site Number 6160017 | Gdansk | Poland | 80-462 | |
| 345 | Investigational Site Number 6160002 | Grodzisk Mazowiecki | Poland | 05-825 | |
| 346 | Investigational Site Number 6160014 | Katowice | Poland | 40-635 | |
| 347 | Investigational Site Number 6160021 | Krakow | Poland | 30-693 | |
| 348 | Investigational Site Number 6160001 | Krakow | Poland | 31 -202 | |
| 349 | Investigational Site Number 6160003 | Krakow | Poland | 31-501 | |
| 350 | Investigational Site Number 6160012 | Krakow | Poland | ||
| 351 | Investigational Site Number 6160011 | Leczna | Poland | 21-010 | |
| 352 | Investigational Site Number 6160016 | Lubin | Poland | 59-301 | |
| 353 | Investigational Site Number 6160005 | Miechow | Poland | 32-200 | |
| 354 | Investigational Site Number 6160022 | Poznan | Poland | 61-848 | |
| 355 | Investigational Site Number 6160006 | Torun | Poland | 87-100 | |
| 356 | Investigational Site Number 6160013 | Warszawa | Poland | 00-685 | |
| 357 | Investigational Site Number 6160004 | Warszawa | Poland | 03-242 | |
| 358 | Investigational Site Number 6160020 | Warszawa | Poland | 04-073 | |
| 359 | Investigational Site Number 6160024 | Warszawa | Poland | 04-349 | |
| 360 | Investigational Site Number 6160008 | Warszawa | Poland | 04-628 | |
| 361 | Investigational Site Number 6160015 | Zamosc | Poland | 22-400 | |
| 362 | Investigational Site Number 6200012 | Braga | Portugal | 4710-243 | |
| 363 | Investigational Site Number 6200001 | Coimbra | Portugal | 3000-075 | |
| 364 | Investigational Site Number 6200011 | Guilhufe - Penafiel | Portugal | 4564-007 | |
| 365 | Investigational Site Number 6200004 | Guimarães | Portugal | 4810-061 | |
| 366 | Investigational Site Number 6200006 | Lisboa | Portugal | 1449-005 | |
| 367 | Investigational Site Number 6200002 | Lisboa | Portugal | 1500-650 | |
| 368 | Investigational Site Number 6200008 | Porto | Portugal | 4099-001 | |
| 369 | Investigational Site Number 6200007 | Vila Franca De Xira | Portugal | 2600-009 | |
| 370 | Investigational Site Number 6200003 | Vila Nova Gaia | Portugal | 4434-502 | |
| 371 | Investigational Site Number 6200005 | Vila Real | Portugal | 5000-508 | |
| 372 | Investigational Site Number 6420014 | Arad | Romania | 310037 | |
| 373 | Investigational Site Number 6420006 | Baia Mare | Romania | 430031 | |
| 374 | Investigational Site Number 6420015 | Braila | Romania | 810325 | |
| 375 | Investigational Site Number 6420013 | Bucharest | Romania | 010825 | |
| 376 | Investigational Site Number 6420019 | Bucuresti | Romania | 014461 | |
| 377 | Investigational Site Number 6420011 | Bucuresti | Romania | 020125 | |
| 378 | Investigational Site Number 6420008 | Bucuresti | Romania | 022322 | |
| 379 | Investigational Site Number 6420007 | Bucuresti | Romania | 050659 | |
| 380 | Investigational Site Number 6420002 | Cluj Napoca | Romania | 400001 | |
| 381 | Investigational Site Number 6420003 | Cluj Napoca | Romania | 400347 | |
| 382 | Investigational Site Number 6420016 | Craiova | Romania | 200642 | |
| 383 | Investigational Site Number 6420005 | Oradea | Romania | 410169 | |
| 384 | Investigational Site Number 6420004 | Oradea | Romania | 410469 | |
| 385 | Investigational Site Number 6420018 | Satu Mare | Romania | 440156 | |
| 386 | Investigational Site Number 6420001 | Targu Mures | Romania | 540103 | |
| 387 | Investigational Site Number 6420012 | Tg-Mures | Romania | 540136 | |
| 388 | Investigational Site Number 6420009 | Timisoara | Romania | 300079 | |
| 389 | Investigational Site Number 6420010 | Timisoara | Romania | 300723 | |
| 390 | Investigational Site Number 6430026 | Ivanovo | Russian Federation | 153012 | |
| 391 | Investigational Site Number 6430023 | Kazan | Russian Federation | 420087 | |
| 392 | Investigational Site Number 6430002 | Kemerovo | Russian Federation | 650002 | |
| 393 | Investigational Site Number 6430006 | Kemerovo | Russian Federation | 650002 | |
| 394 | Investigational Site Number 6430005 | Moscow | Russian Federation | 109240 | |
| 395 | Investigational Site Number 6430004 | Moscow | Russian Federation | 111539 | |
| 396 | Investigational Site Number 6430022 | Moscow | Russian Federation | 117292 | |
| 397 | Investigational Site Number 6430024 | Moscow | Russian Federation | 119192 | |
| 398 | Investigational Site Number 6430001 | Moscow | Russian Federation | 121552 | |
| 399 | Investigational Site Number 6430003 | Moscow | Russian Federation | 121552 | |
| 400 | Investigational Site Number 6430010 | Moscow | Russian Federation | 121552 | |
| 401 | Investigational Site Number 6430018 | Nizhniy Novgorod | Russian Federation | 603005 | |
| 402 | Investigational Site Number 6430013 | Rostov-Na-Donu | Russian Federation | 344068 | |
| 403 | Investigational Site Number 6430011 | Saint-Petersburg | Russian Federation | 198205 | |
| 404 | Investigational Site Number 6430017 | Sochi | Russian Federation | 354057 | |
| 405 | Investigational Site Number 6430025 | St-Petersburg | Russian Federation | 193312 | |
| 406 | Investigational Site Number 6430007 | St-Petersburg | Russian Federation | 195067 | |
| 407 | Investigational Site Number 6430012 | St-Petersburg | Russian Federation | 197341 | |
| 408 | Investigational Site Number 6430009 | St-Petersburg | Russian Federation | 199106 | |
| 409 | Investigational Site Number 6430016 | Tomsk | Russian Federation | 634012 | |
| 410 | Investigational Site Number 7030003 | Bratislava 3 - Kramare | Slovakia | 833 05 | |
| 411 | Investigational Site Number 7030004 | Bratislava 37 | Slovakia | 833 48 | |
| 412 | Investigational Site Number 7030001 | Bratislava | Slovakia | 813 69 | |
| 413 | Investigational Site Number 7030010 | Brezno | Slovakia | 97742 | |
| 414 | Investigational Site Number 7030009 | Dolny Kubin | Slovakia | 02614 | |
| 415 | Investigational Site Number 7030002 | Kosice | Slovakia | 040 01 | |
| 416 | Investigational Site Number 7030011 | Nitra | Slovakia | 950 01 | |
| 417 | Investigational Site Number 7030008 | Trnava | Slovakia | 91775 | |
| 418 | Investigational Site Number 7240016 | Alicante | Spain | 03010 | |
| 419 | Investigational Site Number 7240015 | Badalona | Spain | 08916 | |
| 420 | Investigational Site Number 7240020 | Hospitalet De Llobregat | Spain | 08907 | |
| 421 | Investigational Site Number 7240006 | La Coruña | Spain | 15006 | |
| 422 | Investigational Site Number 7240005 | Las Palmas De Gran Canaria | Spain | 35020 | |
| 423 | Investigational Site Number 7240021 | Madrid | Spain | 28031 | |
| 424 | Investigational Site Number 7240008 | Madrid | Spain | 28040 | |
| 425 | Investigational Site Number 7240022 | Manises | Spain | 46940 | |
| 426 | Investigational Site Number 7240007 | Murcia | Spain | 30120 | |
| 427 | Investigational Site Number 7240004 | Málaga | Spain | 29010 | |
| 428 | Investigational Site Number 7240014 | Olot | Spain | 17800 | |
| 429 | Investigational Site Number 7240009 | San Sebastián De Los Reyes | Spain | 28702 | |
| 430 | Investigational Site Number 7240003 | Sanlúcar De Barrameda | Spain | 11540 | |
| 431 | Investigational Site Number 7240001 | Sevilla | Spain | 41014 | |
| 432 | Investigational Site Number 7240019 | Sevilla | Spain | 41071 | |
| 433 | Investigational Site Number 7240012 | Valencia | Spain | 46010 | |
| 434 | Investigational Site Number 7240011 | Valencia | Spain | 46014 | |
| 435 | Investigational Site Number 7240010 | Valencia | Spain | 46026 | |
| 436 | Investigational Site Number 7240002 | Villamartín | Spain | 11650 | |
| 437 | Investigational Site Number 7240013 | Zaragoza | Spain | 50009 | |
| 438 | Investigational Site Number 7240018 | Úbeda | Spain | 23400 | |
| 439 | Investigational Site Number 7520004 | Jönköping | Sweden | 551 85 | |
| 440 | Investigational Site Number 7520002 | Malmö | Sweden | 205 02 | |
| 441 | Investigational Site Number 7520006 | Skellefteå | Sweden | 931 86 | |
| 442 | Investigational Site Number 7520007 | Stockholm | Sweden | 118 83 | |
| 443 | Investigational Site Number 7520008 | Stockholm | Sweden | 14186 | |
| 444 | Investigational Site Number 7520001 | Stockholm | Sweden | 171 76 | |
| 445 | Investigational Site Number 7560001 | Basel | Switzerland | 4031 | |
| 446 | Investigational Site Number 7560003 | Lugano | Switzerland | 6900 | |
| 447 | Investigational Site Number 7920008 | Antalya | Turkey | 07059 | |
| 448 | Investigational Site Number 7920006 | Corum | Turkey | 19200 | |
| 449 | Investigational Site Number 7920005 | Eskisehir | Turkey | 26480 | |
| 450 | Investigational Site Number 7920002 | Haseki/ Istanbul | Turkey | 34034 | |
| 451 | Investigational Site Number 7920011 | Istanbul | Turkey | 34098 | |
| 452 | Investigational Site Number 7920012 | Izmir | Turkey | 35340 | |
| 453 | Investigational Site Number 7920003 | Kocaeli | Turkey | 41300 | |
| 454 | Investigational Site Number 7920004 | Mersin | Turkey | 33169 | |
| 455 | Investigational Site Number 7920001 | Sivas | Turkey | 58140 | |
| 456 | Investigational Site Number 7920010 | Trabzon | Turkey | 61040 | |
| 457 | Investigational Site Number 8260005 | Bournemouth | United Kingdom | BH7 7DW | |
| 458 | Investigational Site Number 8260010 | Bristol | United Kingdom | BS10 5NB | |
| 459 | Investigational Site Number 8260008 | Chelmsford | United Kingdom | CM1 7ET | |
| 460 | Investigational Site Number 8260009 | Hull | United Kingdom | HU16 5JQ | |
| 461 | Investigational Site Number 8260002 | Newcastle | United Kingdom | NE1 4LP | |
| 462 | Investigational Site Number 8260001 | Oldham | United Kingdom | OL1 2JH | |
| 463 | Investigational Site Number 8260003 | Swansea | United Kingdom | SA6 6NL | |
| 464 | Investigational Site Number 8260006 | Swindon | United Kingdom | SN3 6BB | |
| 465 | Investigational Site Number 8260004 | Torquay | United Kingdom | TQ2 7AA | |
| 466 | Investigational Site Number 8260007 | York | United Kingdom | YO31 8HE |
Sponsors and Collaborators
- Lexicon Pharmaceuticals
- Sanofi
Investigators
- Study Director: Suman Wason, MD, Lexicon Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03521934
Other Study ID Numbers:
- EFC15156
- 2017-003510-16
- U1111-1190-7891
First Posted:
May 11, 2018
Last Update Posted:
Nov 5, 2020
Last Verified:
Nov 1, 2020
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
Additional relevant MeSH terms: