Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
- Conditions
- Type 2 Diabetes MellitusHeart Failure
- Interventions
- Drug: Placebo
- Registration Number
- NCT03521934
- Lead Sponsor
- Lexicon Pharmaceuticals
- 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 participants 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 Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score
* Change in estimated glomerular filtration rate (eGFR)
- Detailed Description
The estimated study duration for a given participants will be approximately 3 to 24 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1222
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months. Sotagliflozin Sotagliflozin Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
- Primary Outcome Measures
Name Time Method Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) Up to 21.9 months Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
- Secondary Outcome Measures
Name Time Method Total Number of Deaths From Any Cause Up to 21.9 months Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Baseline up to 21.9 months eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2). A mixed model for repeated measures (MMRM) was used for analysis.
Total Number of Occurrences of HHF and Urgent HF Visits Up to 21.9 months Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke Up to 21.9 months Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4 Baseline to Month 4 KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.
Total Number of Deaths From Cardiovascular Causes Up to 21.9 months Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized Up to 21.9 months Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Trial Locations
- Locations (466)
Investigational Site Number 8400057
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 8400095
🇺🇸Maumee, Ohio, United States
Investigational Site Number 8400115
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 8400073
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 8400012
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 6160012
🇵🇱Krakow, Poland
Investigational Site Number 6160016
🇵🇱Lubin, Poland
Investigational Site Number 8400055
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number 8400087
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 8400047
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 8400016
🇺🇸Houston, Texas, United States
Investigational Site Number 8400080
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8400075
🇺🇸Bakersfield, California, United States
Investigational Site Number 8400029
🇺🇸Bridgeport, Connecticut, United States
Investigational Site Number 8400028
🇺🇸Walnut Creek, California, United States
Investigational Site Number 8400082
🇺🇸Pensacola, Florida, United States
Investigational Site Number 8400063
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400007
🇺🇸Redondo Beach, California, United States
Investigational Site Number 8400008
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400128
🇺🇸Alexander City, Alabama, United States
Investigational Site Number 8400069
🇺🇸Fresno, California, United States
Investigational Site Number 8400032
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8400109
🇺🇸Cottonwood, Arizona, United States
Investigational Site Number 8400079
🇺🇸Homestead, Florida, United States
Investigational Site Number 8400098
🇺🇸Lake Mary, Florida, United States
Investigational Site Number 8400031
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 8400058
🇺🇸Miami Beach, Florida, United States
Investigational Site Number 8400118
🇺🇸Tucker, Georgia, United States
Investigational Site Number 8400100
🇺🇸Warwick, Rhode Island, United States
Investigational Site Number 0560004
🇧🇪Kortrijk, Belgium
Investigational Site Number 1240019
🇨🇦Montreal, Canada
Investigational Site Number 1240013
🇨🇦Cambridge, Canada
Investigational Site Number 0760006
🇧🇷Campinas, Brazil
Investigational Site Number 0560003
🇧🇪Liège, Belgium
Investigational Site Number 1240018
🇨🇦Montreal, Canada
Investigational Site Number 0320002
🇦🇷Ciudad De Buenos Aires, Argentina
Investigational Site Number 0760023
🇧🇷Fortaleza, Brazil
Investigational Site Number 0760009
🇧🇷Belo Horizonte, Brazil
Investigational Site Number 0760004
🇧🇷Recife, Brazil
Investigational Site Number 0400007
🇦🇹Graz, Austria
Investigational Site Number 0560005
🇧🇪Mol, Belgium
Investigational Site Number 0560008
🇧🇪Roeselare, Belgium
Investigational Site Number 0360007
🇦🇺Murdoch, Australia
Investigational Site Number 0320016
🇦🇷Capital Federal, Argentina
Investigational Site Number 0360001
🇦🇺Wollongong, Australia
Investigational Site Number 0760024
🇧🇷Belo Horizonte, Brazil
Investigational Site Number 0760002
🇧🇷Blumenau, Brazil
Investigational Site Number 0400006
🇦🇹Braunau, Austria
Investigational Site Number 0560007
🇧🇪Gent, Belgium
Investigational Site Number 0320022
🇦🇷Corrientes, Argentina
Investigational Site Number 0760021
🇧🇷Porto Alegre, Brazil
Investigational Site Number 0760020
🇧🇷Porto Alegre, Brazil
Investigational Site Number 1240002
🇨🇦Montreal, Canada
Investigational Site Number 0760005
🇧🇷Campinas, Brazil
Investigational Site Number 1240006
🇨🇦Granby, Canada
Investigational Site Number 1520004
🇨🇱Santiago, Chile
Investigational Site Number 0760011
🇧🇷Brasilia, Brazil
Investigational Site Number 0760001
🇧🇷Sao Jose Do Rio Preto, Brazil
Investigational Site Number 1240014
🇨🇦Quebec, Canada
Investigational Site Number 2030015
🇨🇿Pribram I, Czechia
Investigational Site Number 1240009
🇨🇦Trois-Rivières, Canada
Investigational Site Number 2760001
🇩🇪Berlin, Germany
Investigational Site Number 1520011
🇨🇱Santiago, Chile
Investigational Site Number 2030002
🇨🇿Praha 2, Czechia
Investigational Site Number 2030011
🇨🇿Prerov, Czechia
Investigational Site Number 2500008
🇫🇷La Tronche, France
Investigational Site Number 2500002
🇫🇷Le Coudray, France
Investigational Site Number 2760019
🇩🇪Berlin, Germany
Investigational Site Number 1240001
🇨🇦Toronto, Canada
Investigational Site Number 1240007
🇨🇦Scarborough, Canada
Investigational Site Number 2760016
🇩🇪Bad Oeynhausen, Germany
Investigational Site Number 2030018
🇨🇿Praha 10, Czechia
Investigational Site Number 2760020
🇩🇪Bad Nauheim, Germany
Investigational Site Number 1240011
🇨🇦Toronto, Canada
Investigational Site Number 2760013
🇩🇪Berlin, Germany
Investigational Site Number 2460004
🇫🇮Espoo, Finland
Investigational Site Number 2460003
🇫🇮Oulu, Finland
Investigational Site Number 2500005
🇫🇷Toulouse Cedex 9, France
Investigational Site Number 2080005
🇩🇰København Nv, Denmark
Investigational Site Number 2760018
🇩🇪Essen, Germany
Investigational Site Number 2030007
🇨🇿Praha 5 - Motol, Czechia
Investigational Site Number 2030017
🇨🇿Praha 5, Czechia
Investigational Site Number 3000004
🇬🇷Athens, Greece
Investigational Site Number 2760025
🇩🇪Bielefeld, Germany
Investigational Site Number 3480002
🇭🇺Dombóvár, Hungary
Investigational Site Number 2760005
🇩🇪Bonn, Germany
Investigational Site Number 3000003
🇬🇷Haidari, Greece
Investigational Site Number 3000009
🇬🇷Elefsina, Greece
Investigational Site Number 3000005
🇬🇷Heraklion, Greece
Investigational Site Number 2760021
🇩🇪Bremen, Germany
Investigational Site Number 2760032
🇩🇪Dortmund, Germany
Investigational Site Number 2760006
🇩🇪Dortmund, Germany
Investigational Site Number 2760029
🇩🇪Erfurt, Germany
Investigational Site Number 2500006
🇫🇷Paris, France
Investigational Site Number 2760002
🇩🇪Berlin, Germany
Investigational Site Number 3480010
🇭🇺Budapest, Hungary
Investigational Site Number 3000012
🇬🇷Athens, Greece
Investigational Site Number 3000006
🇬🇷Larissa, Greece
Investigational Site Number 2760030
🇩🇪Langen, Germany
Investigational Site Number 3760004
🇮🇱Hadera, Israel
Investigational Site Number 3480011
🇭🇺Budapest, Hungary
Investigational Site Number 3480019
🇭🇺Budapest, Hungary
Investigational Site Number 3760006
🇮🇱Jerusalem, Israel
Investigational Site Number 3480014
🇭🇺Budapest, Hungary
Investigational Site Number 3800022
🇮🇹Napoli, Italy
Investigational Site Number 3800010
🇮🇹Roma, Italy
Investigational Site Number 3000007
🇬🇷Ioannina, Greece
Investigational Site Number 2760007
🇩🇪Witten, Germany
Investigational Site Number 3800005
🇮🇹Cortona, Italy
Investigational Site Number 3480017
🇭🇺Gyula, Hungary
Investigational Site Number 3480006
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 2760026
🇩🇪Würzburg, Germany
Investigational Site Number 3760009
🇮🇱Safed, Israel
Investigational Site Number 3760002
🇮🇱Petah-Tikva, Israel
Investigational Site Number 3800008
🇮🇹Milano, Italy
Investigational Site Number 3800016
🇮🇹Pozzilli, Italy
Investigational Site Number 3480008
🇭🇺Hódmezövásárhely, Hungary
Investigational Site Number 3000002
🇬🇷Chalkida, Greece
Investigational Site Number 3800018
🇮🇹Pavia, Italy
Investigational Site Number 3800004
🇮🇹Perugia, Italy
Investigational Site Number 3800007
🇮🇹Udine, Italy
Investigational Site Number 3760008
🇮🇱Jerusalem, Israel
Investigational Site Number 3480005
🇭🇺Budapest, Hungary
Investigational Site Number 3480009
🇭🇺Komárom, Hungary
Investigational Site Number 3480018
🇭🇺Berettyóújfalu, Hungary
Investigational Site Number 3480007
🇭🇺Debrecen, Hungary
Investigational Site Number 3760012
🇮🇱Tiberias, Israel
Investigational Site Number 4100004
🇰🇷Daegu, Korea, Republic of
Investigational Site Number 3760010
🇮🇱Nahariya, Israel
Investigational Site Number 2760027
🇩🇪Köln, Germany
Investigational Site Number 3760005
🇮🇱Haifa, Israel
Investigational Site Number 3760001
🇮🇱Tel Aviv, Israel
Investigational Site Number 4280001
🇱🇻Riga, Latvia
Investigational Site Number 3800006
🇮🇹Arzignano (Vi), Italy
Investigational Site Number 3800011
🇮🇹Brescia, Italy
Investigational Site Number 3800021
🇮🇹Roma, Italy
Investigational Site Number 3760003
🇮🇱Jerusalem, Israel
Investigational Site Number 3480020
🇭🇺Kistarcsa, Hungary
Investigational Site Number 4100005
🇰🇷Seongnam-Si, Korea, Republic of
Investigational Site Number 4100003
🇰🇷Incheon, Korea, Republic of
Investigational Site Number 3800009
🇮🇹Ferrara, Italy
Investigational Site Number 4100002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100001
🇰🇷Hwaseong-Si, Korea, Republic of
Investigational Site Number 4280002
🇱🇻Liepaja, Latvia
Investigational Site Number 3800014
🇮🇹Rimini, Italy
Investigational Site Number 4400005
🇱🇹Kaunas, Lithuania
Investigational Site Number 5280005
🇳🇱Veldhoven, Netherlands
Investigational Site Number 4280003
🇱🇻Riga, Latvia
Investigational Site Number 4100011
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100009
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 8260005
🇬🇧Bournemouth, United Kingdom
Investigational Site Number 5280003
🇳🇱Amsterdam, Netherlands
Investigational Site Number 5280002
🇳🇱Doetinchem, Netherlands
Investigational Site Number 6420013
🇷🇴Bucharest, Romania
Investigational Site Number 7520007
🇸🇪Stockholm, Sweden
Investigational Site Number 7920006
🇹🇷Corum, Turkey
Investigational Site Number 7240006
🇪🇸La Coruña, Spain
Investigational Site Number 7240009
🇪🇸San Sebastián De Los Reyes, Spain
Investigational Site Number 7240014
🇪🇸Olot, Spain
Investigational Site Number 7240008
🇪🇸Madrid, Spain
Investigational Site Number 7240015
🇪🇸Badalona, Spain
Investigational Site Number 8260010
🇬🇧Bristol, United Kingdom
Investigational Site Number 7240007
🇪🇸Murcia, Spain
Investigational Site Number 7240021
🇪🇸Madrid, Spain
Investigational Site Number 6420009
🇷🇴Timisoara, Romania
Investigational Site Number 7030008
🇸🇰Trnava, Slovakia
Investigational Site Number 7520004
🇸🇪Jönköping, Sweden
Investigational Site Number 8260007
🇬🇧York, United Kingdom
Investigational Site Number 7240022
🇪🇸Manises, Spain
Investigational Site Number 6430005
🇷🇺Moscow, Russian Federation
Investigational Site Number 7520008
🇸🇪Stockholm, Sweden
Investigational Site Number 7920012
🇹🇷Izmir, Turkey
Investigational Site Number 7920001
🇹🇷Sivas, Turkey
Investigational Site Number 7240016
🇪🇸Alicante, Spain
Investigational Site Number 7240019
🇪🇸Sevilla, Spain
Investigational Site Number 8260004
🇬🇧Torquay, United Kingdom
Investigational Site Number 7520006
🇸🇪Skellefteå, Sweden
Investigational Site Number 7920008
🇹🇷Antalya, Turkey
Investigational Site Number 7920005
🇹🇷Eskisehir, Turkey
Investigational Site Number 7920002
🇹🇷Haseki/ Istanbul, Turkey
Investigational Site Number 7920011
🇹🇷Istanbul, Turkey
Investigational Site Number 6430018
🇷🇺Nizhniy Novgorod, Russian Federation
Investigational Site Number 7240020
🇪🇸Hospitalet De Llobregat, Spain
Investigational Site Number 7240001
🇪🇸Sevilla, Spain
Investigational Site Number 7240013
🇪🇸Zaragoza, Spain
Investigational Site Number 7240002
🇪🇸Villamartín, Spain
Investigational Site Number 7240005
🇪🇸Las Palmas De Gran Canaria, Spain
Investigational Site Number 7920004
🇹🇷Mersin, Turkey
Investigational Site Number 8260006
🇬🇧Swindon, United Kingdom
Investigational Site Number 8260008
🇬🇧Chelmsford, United Kingdom
Investigational Site Number 8260009
🇬🇧Hull, United Kingdom
Investigational Site Number 8260002
🇬🇧Newcastle, United Kingdom
Investigational Site Number 8400105
🇺🇸Orlando, Florida, United States
Investigational Site Number 8400097
🇺🇸Bronx, New York, United States
Investigational Site Number 8400077
🇺🇸Detroit, Michigan, United States
Investigational Site Number 2080003
🇩🇰Aarhus N, Denmark
Investigational Site Number 2080002
🇩🇰Glostrup, Denmark
Investigational Site Number 2080001
🇩🇰Herlev, Denmark
Investigational Site Number 2080004
🇩🇰Ålborg, Denmark
Investigational Site Number 7520002
🇸🇪Malmö, Sweden
Investigational Site Number 7520001
🇸🇪Stockholm, Sweden
Investigational Site Number 3800020
🇮🇹Gallipoli, Italy
Investigational Site Number 3800003
🇮🇹Legnago, Italy
Investigational Site Number 0760018
🇧🇷Goiania, Brazil
Investigational Site Number 0400002
🇦🇹Feldkirch, Austria
Investigational Site Number 0400003
🇦🇹Wien, Austria
Investigational Site Number 0400001
🇦🇹Wien, Austria
Investigational Site Number 1520006
🇨🇱Santiago, Chile
Investigational Site Number 1520012
🇨🇱Santiago, Chile
Investigational Site Number 1520013
🇨🇱Santiago, Chile
Investigational Site Number 2460001
🇫🇮Helsinki, Finland
Investigational Site Number 2460005
🇫🇮Seinäjoki, Finland
Investigational Site Number 0400005
🇦🇹Linz, Austria
Investigational Site Number 1520005
🇨🇱Santiago, Chile
Investigational Site Number 0400004
🇦🇹Salzburg, Austria
Investigational Site Number 1520009
🇨🇱Concepción, Chile
Investigational Site Number 1520002
🇨🇱Temuco, Chile
Investigational Site Number 1520010
🇨🇱Vina Del Mar, Chile
Investigational Site Number 1520001
🇨🇱Viña Del Mar, Chile
Investigational Site Number 2460002
🇫🇮Jyväskylä, Finland
Investigational Site Number 6200011
🇵🇹Guilhufe - Penafiel, Portugal
Investigational Site Number 6200001
🇵🇹Coimbra, Portugal
Investigational Site Number 6200004
🇵🇹Guimarães, Portugal
Investigational Site Number 4400004
🇱🇹Klaipeda, Lithuania
Investigational Site Number 6200012
🇵🇹Braga, Portugal
Investigational Site Number 6200002
🇵🇹Lisboa, Portugal
Investigational Site Number 4400006
🇱🇹Siauliai, Lithuania
Investigational Site Number 4400003
🇱🇹Vilnius, Lithuania
Investigational Site Number 6200006
🇵🇹Lisboa, Portugal
Investigational Site Number 6200003
🇵🇹Vila Nova Gaia, Portugal
Investigational Site Number 6200008
🇵🇹Porto, Portugal
Investigational Site Number 7560003
🇨🇭Lugano, Switzerland
Investigational Site Number 6200007
🇵🇹Vila Franca De Xira, Portugal
Investigational Site Number 6420019
🇷🇴Bucuresti, Romania
Investigational Site Number 6420010
🇷🇴Timisoara, Romania
Investigational Site Number 6200005
🇵🇹Vila Real, Portugal
Investigational Site Number 6420014
🇷🇴Arad, Romania
Investigational Site Number 6420007
🇷🇴Bucuresti, Romania
Investigational Site Number 7030011
🇸🇰Nitra, Slovakia
Investigational Site Number 7560001
🇨🇭Basel, Switzerland
Investigational Site Number 6420006
🇷🇴Baia Mare, Romania
Investigational Site Number 6420015
🇷🇴Braila, Romania
Investigational Site Number 6420003
🇷🇴Cluj Napoca, Romania
Investigational Site Number 6420018
🇷🇴Satu Mare, Romania
Investigational Site Number 6420001
🇷🇴Targu Mures, Romania
Investigational Site Number 7030001
🇸🇰Bratislava, Slovakia
Investigational Site Number 7030009
🇸🇰Dolny Kubin, Slovakia
Investigational Site Number 2500001
🇫🇷Lille, France
Investigational Site Number 2500009
🇫🇷Chambray Les Tours, France
Investigational Site Number 2500003
🇫🇷Paris Cedex 18, France
Investigational Site Number 2500013
🇫🇷Vandoeuvre-Les-Nancy Cedex, France
Investigational Site Number 7920003
🇹🇷Kocaeli, Turkey
Investigational Site Number 7920010
🇹🇷Trabzon, Turkey
Investigational Site Number 8260003
🇬🇧Swansea, United Kingdom
Investigational Site Number 6430009
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 7240003
🇪🇸Sanlúcar De Barrameda, Spain
Investigational Site Number 7240004
🇪🇸Málaga, Spain
Investigational Site Number 7240012
🇪🇸Valencia, Spain
Investigational Site Number 7240011
🇪🇸Valencia, Spain
Investigational Site Number 7240010
🇪🇸Valencia, Spain
Investigational Site Number 7240018
🇪🇸Úbeda, Spain
Investigational Site Number 2760036
🇩🇪Limburg, Germany
Investigational Site Number 2760028
🇩🇪Merseburg, Germany
Investigational Site Number 2760033
🇩🇪Frankfurt Am Main, Germany
Investigational Site Number 2760022
🇩🇪Heidelberg, Germany
Investigational Site Number 2760031
🇩🇪Heidelberg, Germany
Investigational Site Number 2760014
🇩🇪Leverkusen, Germany
Investigational Site Number 2760015
🇩🇪Rüsselsheim, Germany
Investigational Site Number 8400083
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 8400071
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 2030006
🇨🇿Slany, Czechia
Investigational Site Number 8400035
🇺🇸Tampa, Florida, United States
Investigational Site Number 8400042
🇺🇸Tampa, Florida, United States
Investigational Site Number 0320015
🇦🇷Santa Fe, Argentina
Investigational Site Number 0320020
🇦🇷San Martin, Argentina
Investigational Site Number 0320014
🇦🇷Villa Maria, Argentina
Investigational Site Number 8400085
🇺🇸Raleigh, North Carolina, United States
Investigational Site Number 8400127
🇺🇸National City, California, United States
Investigational Site Number 8400036
🇺🇸Stockton, California, United States
Investigational Site Number 8400033
🇺🇸Sylmar, California, United States
Investigational Site Number 8400022
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 8400049
🇺🇸Torrance, California, United States
Investigational Site Number 8400046
🇺🇸DeLand, Florida, United States
Investigational Site Number 8400004
🇺🇸Wellington, Florida, United States
Investigational Site Number 8400006
🇺🇸Sarasota, Florida, United States
Investigational Site Number 8400067
🇺🇸Arlington Heights, Illinois, United States
Investigational Site Number 8400043
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8400020
🇺🇸Muncie, Indiana, United States
Investigational Site Number 8400072
🇺🇸Elk Grove Village, Illinois, United States
Investigational Site Number 8400122
🇺🇸Richmond, Indiana, United States
Investigational Site Number 8400001
🇺🇸Cambridge, Massachusetts, United States
Investigational Site Number 8400062
🇺🇸Kalamazoo, Michigan, United States
Investigational Site Number 8400056
🇺🇸Jackson, Mississippi, United States
Investigational Site Number 8400017
🇺🇸Kalamazoo, Michigan, United States
Investigational Site Number 8400019
🇺🇸Columbia, Missouri, United States
Investigational Site Number 8400107
🇺🇸Duluth, Minnesota, United States
Investigational Site Number 8400103
🇺🇸Lee's Summit, Missouri, United States
Investigational Site Number 8400132
🇺🇸Grand Island, Nebraska, United States
Investigational Site Number 8400130
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 8400015
🇺🇸Ridgewood, New Jersey, United States
Investigational Site Number 8400131
🇺🇸Albuquerque, New Mexico, United States
Investigational Site Number 8400050
🇺🇸Voorhees, New Jersey, United States
Investigational Site Number 8400051
🇺🇸Brooklyn, New York, United States
Investigational Site Number 8400111
🇺🇸Buffalo, New York, United States
Investigational Site Number 8400045
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8400121
🇺🇸Zanesville, Ohio, United States
Investigational Site Number 8400134
🇺🇸Doylestown, Pennsylvania, United States
Investigational Site Number 8400054
🇺🇸Arlington, Oregon, United States
Investigational Site Number 8400039
🇺🇸Sayre, Pennsylvania, United States
Investigational Site Number 8400044
🇺🇸Natrona Heights, Pennsylvania, United States
Investigational Site Number 8400114
🇺🇸Providence, Rhode Island, United States
Investigational Site Number 8400092
🇺🇸Columbia, South Carolina, United States
Investigational Site Number 8400104
🇺🇸Greenville, South Carolina, United States
Investigational Site Number 8400040
🇺🇸Rapid City, South Dakota, United States
Investigational Site Number 8400089
🇺🇸Memphis, Tennessee, United States
Investigational Site Number 8400088
🇺🇸Greenville, Tennessee, United States
Investigational Site Number 8400041
🇺🇸Brownsville, Texas, United States
Investigational Site Number 8400053
🇺🇸Nashville, Tennessee, United States
Investigational Site Number 8400123
🇺🇸McKinney, Texas, United States
Investigational Site Number 8400066
🇺🇸Victoria, Texas, United States
Investigational Site Number 8400093
🇺🇸Manassas, Virginia, United States
Investigational Site Number 8400126
🇺🇸Clarksburg, West Virginia, United States
Investigational Site Number 8400038
🇺🇸Morgantown, West Virginia, United States
Investigational Site Number 8400048
🇺🇸Manitowoc, Wisconsin, United States
Investigational Site Number 0320031
🇦🇷Caba, Argentina
Investigational Site Number 0320009
🇦🇷Caba, Argentina
Investigational Site Number 8400074
🇺🇸Dallas, Texas, United States
Investigational Site Number 8400101
🇺🇸New Braunfels, Texas, United States
Investigational Site Number 0320011
🇦🇷Cordoba, Argentina
Investigational Site Number 0320010
🇦🇷Cordoba, Argentina
Investigational Site Number 0320001
🇦🇷Corrientes, Argentina
Investigational Site Number 0320029
🇦🇷La Plata, Argentina
Investigational Site Number 0320025
🇦🇷Córdoba, Argentina
Investigational Site Number 0320003
🇦🇷Córdoba, Argentina
Investigational Site Number 0320024
🇦🇷Córdoba, Argentina
Investigational Site Number 0320006
🇦🇷Merlo, Argentina
Investigational Site Number 0320018
🇦🇷Rosario, Argentina
Investigational Site Number 0320012
🇦🇷Olivos, Argentina
Investigational Site Number 0320007
🇦🇷La Plata, Argentina
Investigational Site Number 0320023
🇦🇷Quilmes, Argentina
Investigational Site Number 0320005
🇦🇷Moron, Argentina
Investigational Site Number 0320013
🇦🇷Rosario, Argentina
Investigational Site Number 0320008
🇦🇷Salta, Argentina
Investigational Site Number 0320028
🇦🇷San Miguel De Tucuman, Argentina
Investigational Site Number 0320017
🇦🇷Santa Fe, Argentina
Investigational Site Number 0320019
🇦🇷San Miguel De Tucuman, Argentina
Investigational Site Number 0320030
🇦🇷Tucuman, Argentina
Investigational Site Number 0320004
🇦🇷Villa Belgrano, Argentina
Investigational Site Number 0560001
🇧🇪Leuven, Belgium
Investigational Site Number 0560002
🇧🇪Aalst, Belgium
Investigational Site Number 0760008
🇧🇷Sao Paulo, Brazil
Investigational Site Number 0760010
🇧🇷Passo Fundo, Brazil
Investigational Site Number 0760003
🇧🇷Porto Alegre, Brazil
Investigational Site Number 0760013
🇧🇷Porto Alegre, Brazil
Investigational Site Number 0760007
🇧🇷Porto Alegre, Brazil
Investigational Site Number 0760017
🇧🇷Votuporanga, Brazil
Investigational Site Number 0760012
🇧🇷Sao Paulo, Brazil
Investigational Site Number 1240015
🇨🇦Halifax, Canada
Investigational Site Number 1240004
🇨🇦Peterborough, Canada
Investigational Site Number 2030004
🇨🇿Brno, Czechia
Investigational Site Number 1240005
🇨🇦Sherbrooke, Canada
Investigational Site Number 1520003
🇨🇱Santiago, Chile
Investigational Site Number 2030003
🇨🇿Brno, Czechia
Investigational Site Number 2030001
🇨🇿Brno, Czechia
Investigational Site Number 2030010
🇨🇿Kromeriz, Czechia
Investigational Site Number 2030005
🇨🇿Liberec, Czechia
Investigational Site Number 2030014
🇨🇿Kolin 3, Czechia
Investigational Site Number 2030013
🇨🇿Mestec Kralove, Czechia
Investigational Site Number 2500004
🇫🇷Le Chesnay, France
Investigational Site Number 2500012
🇫🇷Nice Cedex 1, France
Investigational Site Number 2500007
🇫🇷Nantes Cedex 1, France
Investigational Site Number 2760035
🇩🇪Coburg, Germany
Investigational Site Number 2760034
🇩🇪Lahr, Germany
Investigational Site Number 2760012
🇩🇪Ludwigshafen, Germany
Investigational Site Number 2760009
🇩🇪Greifswald, Germany
Investigational Site Number 2760011
🇩🇪Rotenburg An Der Fulda, Germany
Investigational Site Number 3480016
🇭🇺Budapest, Hungary
Investigational Site Number 3000008
🇬🇷Thessaloniki, Greece
Investigational Site Number 3000001
🇬🇷N. Ionia, Greece
Investigational Site Number 3480012
🇭🇺Budapest, Hungary
Investigational Site Number 3480001
🇭🇺Budapest, Hungary
Investigational Site Number 3480015
🇭🇺Budapest, Hungary
Investigational Site Number 3480003
🇭🇺Szekesfehervar, Hungary
Investigational Site Number 3760013
🇮🇱Ashkelon, Israel
Investigational Site Number 3480013
🇭🇺Pécs, Hungary
Investigational Site Number 3760011
🇮🇱Rehovot, Israel
Investigational Site Number 3800023
🇮🇹Milano, Italy
Investigational Site Number 3800017
🇮🇹Brescia, Italy
Investigational Site Number 3800012
🇮🇹Milano, Italy
Investigational Site Number 3800013
🇮🇹Monza, Italy
Investigational Site Number 3800002
🇮🇹Milano, Italy
Investigational Site Number 5540007
🇳🇿Auckland, New Zealand
Investigational Site Number 6160014
🇵🇱Katowice, Poland
Investigational Site Number 4100010
🇰🇷Busan, Korea, Republic of
Investigational Site Number 4100008
🇰🇷Bucheon-Si, Korea, Republic of
Investigational Site Number 3800019
🇮🇹Scorrano, Italy
Investigational Site Number 4100007
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4280004
🇱🇻Daugavpils, Latvia
Investigational Site Number 4400002
🇱🇹Kaunas, Lithuania
Investigational Site Number 4400001
🇱🇹Vilnius, Lithuania
Investigational Site Number 5280001
🇳🇱Breda, Netherlands
Investigational Site Number 5280007
🇳🇱Delft, Netherlands
Investigational Site Number 5280004
🇳🇱Hertogenbosch, Netherlands
Investigational Site Number 5280006
🇳🇱Rotterdam, Netherlands
Investigational Site Number 5280008
🇳🇱Sneek, Netherlands
Investigational Site Number 5540002
🇳🇿Hamilton, New Zealand
Investigational Site Number 5540005
🇳🇿New Plymouth, New Zealand
Investigational Site Number 5540004
🇳🇿Lower Hutt, New Zealand
Investigational Site Number 5540006
🇳🇿Christchurch, New Zealand
Investigational Site Number 5540003
🇳🇿Rotorua, New Zealand
Investigational Site Number 6160007
🇵🇱Bialystok, Poland
Investigational Site Number 6160017
🇵🇱Gdansk, Poland
Investigational Site Number 6160001
🇵🇱Krakow, Poland
Investigational Site Number 6160003
🇵🇱Krakow, Poland
Investigational Site Number 6160002
🇵🇱Grodzisk Mazowiecki, Poland
Investigational Site Number 6160011
🇵🇱Leczna, Poland
Investigational Site Number 6160008
🇵🇱Warszawa, Poland
Investigational Site Number 6160005
🇵🇱Miechow, Poland
Investigational Site Number 6160006
🇵🇱Torun, Poland
Investigational Site Number 6160004
🇵🇱Warszawa, Poland
Investigational Site Number 6160020
🇵🇱Warszawa, Poland
Investigational Site Number 6160024
🇵🇱Warszawa, Poland
Investigational Site Number 6420011
🇷🇴Bucuresti, Romania
Investigational Site Number 6420008
🇷🇴Bucuresti, Romania
Investigational Site Number 6420002
🇷🇴Cluj Napoca, Romania
Investigational Site Number 6420016
🇷🇴Craiova, Romania
Investigational Site Number 6420004
🇷🇴Oradea, Romania
Investigational Site Number 6420005
🇷🇴Oradea, Romania
Investigational Site Number 6420012
🇷🇴Tg-Mures, Romania
Investigational Site Number 6430023
🇷🇺Kazan, Russian Federation
Investigational Site Number 6430026
🇷🇺Ivanovo, Russian Federation
Investigational Site Number 6430002
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 6430004
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430006
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 6430022
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430024
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430010
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430003
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430025
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 6430013
🇷🇺Rostov-Na-Donu, Russian Federation
Investigational Site Number 6430007
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 6430017
🇷🇺Sochi, Russian Federation
Investigational Site Number 6430011
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6430012
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 7030003
🇸🇰Bratislava 3 - Kramare, Slovakia
Investigational Site Number 7030004
🇸🇰Bratislava 37, Slovakia
Investigational Site Number 6430016
🇷🇺Tomsk, Russian Federation
Investigational Site Number 7030002
🇸🇰Kosice, Slovakia
Investigational Site Number 7030010
🇸🇰Brezno, Slovakia
Investigational Site Number 8260001
🇬🇧Oldham, United Kingdom
Investigational Site Number 6160021
🇵🇱Krakow, Poland
Investigational Site Number 6160022
🇵🇱Poznan, Poland
Investigational Site Number 6160013
🇵🇱Warszawa, Poland
Investigational Site Number 6160015
🇵🇱Zamosc, Poland
Investigational Site Number 0560006
🇧🇪Mons, Belgium
Investigational Site Number 8400037
🇺🇸New Haven, Connecticut, United States
Investigational Site Number 8400009
🇺🇸Gainesville, Florida, United States
Investigational Site Number 8400061
🇺🇸Bronx, New York, United States
Investigational Site Number 8400003
🇺🇸Richmond, Virginia, United States
Investigational Site Number 8400078
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 8400059
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 8400091
🇺🇸Waterloo, Iowa, United States
Investigational Site Number 8400065
🇺🇸Annapolis, Maryland, United States
Investigational Site Number 8400099
🇺🇸Toledo, Ohio, United States
Investigational Site Number 8400030
🇺🇸Covington, Louisiana, United States