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Clinical Trial Details

Trial ID: L0225
Source ID: NCT02540993
Associated Drug: Finerenone (Bay94-8862)
Title: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Acronym: FIDELIO-DKD
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02540993/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Finerenone (BAY94-8862)|DRUG: Placebo
Outcome Measures: Primary: The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death, Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis., From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months | Secondary: The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure, Count of participants and time from randomization to the first occurrence of the key secondary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis., From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months|All-cause Mortality, Count of participants and time from randomization until death due to any cause were evaluated. Number of participants with outcome death is reported as descriptive result and hazard ratio is reported as statistical analysis. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table., From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months|All-cause Hospitalization, Count of participants and time from randomization to the first occurrence of a hospitalization event were evaluated. Number of participants with the event is reported as descriptive result and hazard ratio is reported as statistical analysis., From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months|Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4, First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change., From baseline up until Month 4|The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death, Count of participants and time from randomization to the first occurrence of the secondary renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis., From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 5734
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-09-17
Completion Date: 2020-04-14
Results First Posted: 2021-07-19
Last Update Posted: 2023-07-24
Locations: Birmingham, Alabama, 35294, United States|Fort Payne, Alabama, 35967, United States|Huntsville, Alabama, 35801-4317, United States|Mesa, Arizona, 85210, United States|Phoenix, Arizona, 85016, United States|Phoenix, Arizona, 85032, United States|Prescott, Arizona, 86301, United States|Tucson, Arizona, 85723, United States|Tucson, Arizona, 85724, United States|Arvin, California, 93203, United States|Chula Vista, California, 91910, United States|Dublin, California, 94568, United States|El Centro, California, 92243, United States|Fresno, California, 93720, United States|Fresno, California, 93721, United States|La Mesa, California, 91942, United States|Loma Linda, California, 92357, United States|Los Angeles, California, 90017, United States|Los Angeles, California, 90022, United States|Los Angeles, California, 90025, United States|Los Angeles, California, 90073, United States|Northridge, California, 91325, United States|Port Hueneme, California, 93041, United States|Poway, California, 92064, United States|Rancho Cucamonga, California, 91730, United States|Rialto, California, 92377, United States|Roseville, California, 95661, United States|San Diego, California, 92117, United States|San Francisco, California, 94110, United States|Torrance, California, 90502, United States|New Haven, Connecticut, 06520, United States|Waterbury, Connecticut, 06708, United States|Fleming Island, Florida, 32003, United States|Fort Lauderdale, Florida, 33316-1958, United States|Gainesville, Florida, 32610-0224, United States|Hialeah, Florida, 33012, United States|Hialeah, Florida, 33016, United States|Hollywood, Florida, 33024, United States|Jacksonville, Florida, 32204, United States|Miami Beach, Florida, 33140, United States|Miami Gardens, Florida, 33169, United States|Miami Lakes, Florida, 33014, United States|Miami Lakes, Florida, 33016, United States|Miami, Florida, 33032, United States|Miami, Florida, 33126, United States|Miami, Florida, 33130, United States|Miami, Florida, 33144, United States|Miami, Florida, 33145, United States|Miami, Florida, 33155, United States|Miami, Florida, 33156, United States|Miami, Florida, 33165, United States|Miami, Florida, 33173, United States|Miami, Florida, 33175, United States|Miami, Florida, 33180, United States|Miami, Florida, 33186, United States|New Port Richey, Florida, 34652, United States|Ocala, Florida, 34471, United States|Orlando, Florida, 32825, United States|Palm Harbor, Florida, 34684, United States|Sarasota, Florida, 34239, United States|Tampa, Florida, 33614, United States|Tampa, Florida, 33619, United States|Winter Haven, Florida, 33880, United States|Atlanta, Georgia, 30303, United States|Atlanta, Georgia, 30318, United States|Atlanta, Georgia, 30342, United States|Augusta, Georgia, 30904, United States|Duluth, Georgia, 30096, United States|Lilburn, Georgia, 30047, United States|Macon, Georgia, 31210, United States|Honolulu, Hawaii, 96814, United States|Chicago, Illinois, 60611, United States|Chicago, Illinois, 60612, United States|Elgin, Illinois, 60123, United States|Indianapolis, Indiana, 46202, United States|Iowa City, Iowa, 52242, United States|Hutchinson, Kansas, 67502-1131, United States|Topeka, Kansas, 66606, United States|Wichita, Kansas, 67214, United States|Metairie, Louisiana, 70006, United States|Monroe, Louisiana, 71201, United States|New Orleans, Louisiana, 70112, United States|Shreveport, Louisiana, 71101, United States|Takoma Park, Maryland, 20912, United States|Boston, Massachusetts, 02215, United States|Ann Arbor, Michigan, 48109, United States|Flint, Michigan, 48504, United States|Flint, Michigan, 48532, United States|Minneapolis, Minnesota, 55455, United States|Columbia, Missouri, 65201, United States|Columbia, Missouri, 65212, United States|Jefferson City, Missouri, 65109, United States|Kansas City, Missouri, 64111, United States|Kansas City, Missouri, 64128, United States|Saint Louis, Missouri, 63106, United States|Saint Louis, Missouri, 63136, United States|Lincoln, Nebraska, 68510, United States|Omaha, Nebraska, 68124, United States|Omaha, Nebraska, 68131, United States|Las Vegas, Nevada, 89086, United States|Las Vegas, Nevada, 89102, United States|Las Vegas, Nevada, 89113-2215, United States|Las Vegas, Nevada, 89119, United States|Las Vegas, Nevada, 89128, United States|Reno, Nevada, 89511, United States|Newark, New Jersey, 07103, United States|Albuquerque, New Mexico, 87106, United States|Albany, New York, 12206, United States|Brooklyn, New York, 11203, United States|Flushing, New York, 11355, United States|Mineola, New York, 11501, United States|New York, New York, 10021, United States|New York, New York, 10029, United States|New York, New York, 10032, United States|Rosedale, New York, 11422, United States|Smithtown, New York, 11787, United States|Staten Island, New York, 10301, United States|Asheboro, North Carolina, 27203, United States|Chapel Hill, North Carolina, 27312, United States|Charlotte, North Carolina, 28207, United States|Greenville, North Carolina, 27834, United States|New Bern, North Carolina, 28562, United States|Winston-Salem, North Carolina, 27103, United States|Winston-Salem, North Carolina, 27157, United States|Canton, Ohio, 44718, United States|Cleveland, Ohio, 44106, United States|Columbus, Ohio, 43210, United States|Beaver, Pennsylvania, 15009, United States|Bethlehem, Pennsylvania, 18017, United States|Hershey, Pennsylvania, 17033, United States|Lansdale, Pennsylvania, 19446-2321, United States|Anderson, South Carolina, 29625, United States|Charleston, South Carolina, 29425, United States|Greenville, South Carolina, 29605, United States|Greer, South Carolina, 29651, United States|Murrells Inlet, South Carolina, 29576, United States|Orangeburg, South Carolina, 29118, United States|Chattanooga, Tennessee, 37404, United States|Memphis, Tennessee, 38120, United States|Memphis, Tennessee, 38163, United States|Nashville, Tennessee, 37205, United States|Nashville, Tennessee, 37208, United States|Nashville, Tennessee, 37232-1371, United States|Arlington, Texas, 76014, United States|Corpus Christi, Texas, 78414-4173, United States|Dallas, Texas, 75216, United States|Dallas, Texas, 75246, United States|Dallas, Texas, 75251, United States|El Paso, Texas, 79935, United States|Houston, Texas, 77008, United States|Houston, Texas, 77024, United States|Houston, Texas, 77040, United States|Houston, Texas, 77061, United States|Houston, Texas, 77079, United States|Houston, Texas, 77095, United States|Kingwood, Texas, 77339, United States|McAllen, Texas, 78503, United States|McKinney, Texas, 75069-1780, United States|Pearland, Texas, 77584, United States|Pflugerville, Texas, 78660, United States|San Antonio, Texas, 78212, United States|San Antonio, Texas, 78215, United States|San Antonio, Texas, 78229-3900, United States|Sugar Land, Texas, 77478, United States|Sugar Land, Texas, 77479, United States|Waco, Texas, 76710, United States|Saint George, Utah, 84790, United States|Salt Lake City, Utah, 84108, United States|Burlington, Vermont, 05401, United States|Alexandria, Virginia, 22304, United States|Manassas, Virginia, 20110, United States|Salem, Virginia, 24153, United States|Virginia Beach, Virginia, 23462, United States|Spokane Valley, Washington, 99216-3522, United States|Tacoma, Washington, 98405, United States|Milwaukee, Wisconsin, 53295, United States|Junín, Buenos Aires, B6000GMA, Argentina|Lanús, Buenos Aires, B1824KAJ, Argentina|Mar del Plata, Buenos Aires, B7602CBM, Argentina|Sarandí, Buenos Aires, 1872, Argentina|Buenos Aires, Ciudad Auton. De Buenos Aires, C1056ABJ, Argentina|Buenos Aires, Ciudad Auton. De Buenos Aires, C1426ABP, Argentina|Buenos Aires, Ciudad Auton. De Buenos Aires, C1428ART, Argentina|Buenos Aires, Ciudad Auton. De Buenos Aires, C1429BWN, Argentina|Caba, Ciudad Auton. De Buenos Aires, C1018DES, Argentina|Ciudad Autón. de Buenos Aires, Ciudad Auton. De Buenos Aires, C1425AGC, Argentina|Córdoba, X5000AAW Córdoba, Argentina|Córdoba, X5000JHQ, Argentina|San Luis, D5702AAx, Argentina|Garran, Australian Capital Territory, 2605, Australia|Gosford, New South Wales, 2250, Australia|Liverpool, New South Wales, 2170, Australia|New Lambton, New South Wales, 2305, Australia|Wollongong, New South Wales, 2500, Australia|Adelaide, South Australia, 5000, Australia|Fitzroy, Victoria, 3065, Australia|Heidelberg, Victoria, 3081, Australia|Reservoir, Victoria, 3073, Australia|Richmond, Victoria, 3121, Australia|St. Albans, Victoria, 3021, Australia|Box Hill, 3128, Australia|Elizabeth Vale, 5112, Australia|Linz, Oberösterreich, 4020, Austria|Linz, Oberösterreich, 4021, Austria|Graz, Steiermark, 8036, Austria|Saint Stefan, Steiermark, 8511, Austria|Feldkirch, Vorarlberg, 6807, Austria|Innsbruck, 6020, Austria|Salzburg, 5020, Austria|St. Pölten, 3100, Austria|Wels, 4600, Austria|Wien, 1030, Austria|Wien, 1060, Austria|Wien, 1090, Austria|Wien, 1130, Austria|Antwerpen, 2060, Belgium|Bruxelles - Brussel, 1070, Belgium|Edegem, 2650, Belgium|Gent, 9000, Belgium|Ieper, 8900, Belgium|Kortrijk, 8500, Belgium|Leuven, 3000, Belgium|Liege, 4000, Belgium|Roeselare, 8800, Belgium|Feira de Santana, Bahia, 44001-584, Brazil|Salvador, Bahia, 40415-065, Brazil|Fortaleza, Ceará, 60115-282, Brazil|Fortaleza, Ceará, 60430-140, Brazil|Fortaleza, Ceará, Brazil|Brasilia, Distrito Federal, 70.200-730, Brazil|Aparecida de Goiania, Goiás, 74935-530, Brazil|Goiania, Goiás, 74605-020, Brazil|Juiz de Fora, Minas Gerais, 36036-330, Brazil|Curitiba, Parana, 80030-110, Brazil|Curitiba, Parana, 80230-130, Brazil|Curitiba, Parana, 80440-020, Brazil|Paraná, Parana, 83430-000, Brazil|Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil|Santo Andre, Sao Paulo, Brazil|São José do Rio Preto, Sao Paulo, 15090-000, Brazil|São José dos Campos, Sao Paulo, 12243-280, Brazil|São Paulo, Sao Paulo, Brazil|Minas Gerais, 38400-368, Brazil|Rio de Janeiro, 20241-180, Brazil|Rio de Janeiro, 21941-913, Brazil|Sao Paulo, 01223-001, Brazil|Sao Paulo, 01228-200, Brazil|Sao Paulo, 04039-000, Brazil|Blagoevgrad, 2700, Bulgaria|Botevgrad, 2140, Bulgaria|Dimitrovgrad, 6400, Bulgaria|Gorna Oryahovitsa, 5100, Bulgaria|Kazanlak, 6102, Bulgaria|Kozloduy, 3320, Bulgaria|Lukovit, 5770, Bulgaria|Plovdiv, 4000, Bulgaria|Plovdiv, 4002, Bulgaria|Plovdiv, 4004, Bulgaria|Razgrad, 7200, Bulgaria|Sliven, 8800, Bulgaria|Smolyan, 4700, Bulgaria|Sofia, 1233, Bulgaria|Sofia, 1407, Bulgaria|Sofia, 1431, Bulgaria|Sofia, 1680, Bulgaria|Stara Zagora, 6000, Bulgaria|Varna, 9000, Bulgaria|Yambol, 8600, Bulgaria|Burnaby, British Columbia, V3J 1N4, Canada|Coquitlam, British Columbia, V3K 3P4, Canada|New Westminster, British Columbia, V3L 0A6, Canada|Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada|St. John's, Newfoundland and Labrador, A1A 3R5, Canada|Halifax, Nova Scotia, B3H 1V8, Canada|Cambridge, Ontario, N1R 7L6, Canada|Hamilton, Ontario, L8M 1K7, Canada|Hamilton, Ontario, L8N 4A6, Canada|Kitchener, Ontario, N2G 4V5, Canada|Newmarket, Ontario, L3Y 5G8, Canada|Oshawa, Ontario, L1G 2B9, Canada|Ottawa, Ontario, K1K 4L2, Canada|Sarnia, Ontario, N7T 4X3, Canada|Smith Falls, Ontario, K7A 4W8, Canada|Sudbury, Ontario, P3A 1W8, Canada|Thornhill, Ontario, L4J 1W3, Canada|Toronto, Ontario, M4G 3E8, Canada|Toronto, Ontario, M5C 2T2, Canada|Waterloo, Ontario, N2J 1C4, Canada|Greenfield Park, Quebec, J4V 2H1, Canada|Laval, Quebec, H7T 2P5, Canada|Mirabel, Quebec, J7J 2K8, Canada|Montreal, Quebec, H1M 1B1, Canada|Montreal, Quebec, H2K 1H2, Canada|Montreal, Quebec, H3G 1A4, Canada|Montreal, Quebec, H4A 3J1, Canada|Montreal, Quebec, H4A 3T2, Canada|Montreal, Quebec, QC H4J 1C5, Canada|Quebec, G1V 4W2, Canada|Osorno, Los Lagos, 5311092, Chile|Las Condes, Santiago, 7591047, Chile|Providencia, Santiago, 7500520, Chile|Providencia, Santiago, 7500710, Chile|Providencia, Santiago, 7500922, Chile|San Bernardo, Santiago, 8053095, Chile|San Miguel, Santiago, 8910108, Chile|Santiago, 8330008, Chile|Santiago, 8331143, Chile|Santiago, 8380456, Chile|Fuzhou, Fujian, 350025, China|Xiamen, Fujian, 361003, China|Xiamen, Fujian, 361004, China|Lanzhou, Gansu, 730030, China|Guangzhou, Guangdong, 510080, China|Guangzhou, Guangdong, 510120, China|Guangzhou, Guangdong, 510150, China|Guangzhou, Guangdong, 510405, China|Guangzhou, Guangdong, 510630, China|Zhuhai, Guangdong, 519000, China|Nanning, Guangxi, 530021, China|Nanning, Guangxi, 530031, China|Haikou, Hainan, 570102, China|Haikou, Hainan, 570311, China|Wuhan, Hubei, 430022, China|Wuhan, Hubei, 430034, China|Changsha, Hunan, 410000, China|Changsha, Hunan, 410008, China|Changsha, Hunan, 410011, China|Changzhou, Jiangsu, 213004, China|Huai'An, Jiangsu, 223300, China|Lianyungang, Jiangsu, 222002, China|Nanjing, Jiangsu, 210000, China|Nanjing, Jiangsu, 210006, China|Nanjing, Jiangsu, 210008, China|Nanjing, Jiangsu, 210029, China|Suzhou, Jiangsu, 215006, China|Wuxi, Jiangsu, 214023, China|Yancheng, Jiangsu, 224000, China|Nanchang, Jiangxi, 330006, China|Nanchang, Jiangxi, 330008, China|Changchun, Jilin, 130000, China|Shenyang, Liaoning, 110016, China|Shenyang, Liaoning, 110022, China|Yinchuan, Ningxia, 750004, China|Xi'an, Shaanxi, 710061, China|Qingdao, Shandong, 266000, China|Qingdao, Shandong, 266071, China|Taiyuan, Shanxi, 030001, China|Chengdu, Sichuan, 610041, China|Chengdu, Sichuan, 610072, China|Hangzhou, Zhejiang, 310013, China|Taizhou, Zhejiang, 317000, China|Wenzhou, Zhejiang, 325000, China|Beijing, 100010, China|Beijing, 100730, China|Chongqing, 400010, China|Shanghai, 200025, China|Shanghai, 200040, China|Shanghai, 200072, China|Shanghai, 200092, China|Shanghai, 200240, China|Shanghai, 200333, China|Shanghai, 201199, China|Tianjin, 300052, China|Tianjin, 300121, China|Tianjin, 300142, China|Medellin, Antioquia, 050023, Colombia|Medellín, Antioquia, 050034, Colombia|Medellín, Antioquia, 0, Colombia|Medellín, Antioquia, Colombia|Baranquilla, Atlántico, 080020, Colombia|Barranquilla, Atlántico, 080020, Colombia|Barranquilla, Atlántico, 0, Colombia|Manizales, Caldas, Colombia|Zipaquira, Cundinamarca, 250252, Colombia|Bogotá, Distrito Capital De Bogotá, 0, Colombia|Cundinamarca, Distrito Capital De Bogotá, Colombia|Armenia, Quindío, 0, Colombia|Cali, Valle Del Cauca, 760032, Colombia|Cali, Valle Del Cauca, Colombia|Floridablanca, Colombia|Medellín, Colombia|Beroun, 266 01, Czechia|Brandys nad Labem, 250 01, Czechia|Breclav, 690 02, Czechia|Ceska Lipa, 470 01, Czechia|Cesky Krumlov, 381 01, Czechia|Cesky Krumlov, 381 27, Czechia|Frydek-Mistek, 738 01, Czechia|Hodonin, 695 01, Czechia|Holesov, 769 01, Czechia|Hranice, 753 01, Czechia|Koprivnice, 742 21, Czechia|Krnov, 794 01, Czechia|Mlada Boleslav, 29301, Czechia|Olomouc, 779 00, Czechia|Olomouc, 77900, Czechia|Ostrava, 702 00, Czechia|Plzen, 301 66, Czechia|Prague 6, 169 00, Czechia|Praha 2, 12808, Czechia|Praha 4, 140 00, Czechia|Praha 4, 140 46, Czechia|Praha 5, 150 00, Czechia|Vlasim, 258 01, Czechia|Aalborg, 9000, Denmark|Aarhus N, 8200, Denmark|Esbjerg, 6700, Denmark|Hellerup, 2900, Denmark|Herlev, 2730, Denmark|Hillerød, 3400, Denmark|Holbæk, 4300, Denmark|Holstebro, DK-7500, Denmark|Hvidovre, 2650, Denmark|Kolding, 6000, Denmark|København NV, 2400, Denmark|Odense C, DK-5000, Denmark|Svendborg, 5700, Denmark|Viborg, 8800, Denmark|Jyväskylä, 40620, Finland|Kajaani, 87140, Finland|Kerava, 04200, Finland|Klaukkala, 01800, Finland|Kuopio, 70100, Finland|Nurmijärvi, 01900, Finland|Oulu, 90100, Finland|Rauma, 26100, Finland|Seinäjoki, 60100, Finland|Tampere, 33520, Finland|Turku, 20521, Finland|Vantaa, 01600, Finland|Bois-guillaume, 76230, France|Bordeaux, 33000, France|Boulogne Sur Mer, 62321, France|Brest, 29200, France|COLMAR Cedex, 68024, France|Dijon, 21000, France|La Rochelle, 17019, France|La Tronche, 38700, France|Le Coudray, 28630, France|Le Creusot, 71200, France|Lyon Cedex, 69437, France|Mulhouse, 68051, France|Nîmes, 30029, France|Paris, 75018, France|PESSAC cedex, 33608, France|Saint Herblain, 44093, France|Saint Priest En Jarez, 42270, France|Tourcoing, 59280, France|Vandoeuvre-les-nancy, 54500, France|Venissieux, 69200, France|Heidelberg, Baden-Württemberg, 69115, Germany|Ludwigsburg, Baden-Württemberg, 71640, Germany|Schweinfurt, Bayern, 97421, Germany|Würzburg, Bayern, 97080, Germany|Elsterwerda, Brandenburg, 04910, Germany|Bad König, Hessen, 64732, Germany|Frankfurt, Hessen, 60313, Germany|Frankfurt, Hessen, 60596, Germany|Göttingen, Niedersachsen, 37075, Germany|Hannover, Niedersachsen, 30625, Germany|Aachen, Nordrhein-Westfalen, 52074, Germany|Bad Oeynhausen, Nordrhein-Westfalen, 32545, Germany|Bochum, Nordrhein-Westfalen, 44787, Germany|Dortmund, Nordrhein-Westfalen, 44137, Germany|Duesseldorf, Nordrhein-Westfalen, 40210, Germany|Düsseldorf, Nordrhein-Westfalen, 40225, Germany|Essen, Nordrhein-Westfalen, 45136, Germany|Münster, Nordrhein-Westfalen, 48145, Germany|Nettetal, Nordrhein-Westfalen, 41334, Germany|Witten, Nordrhein-Westfalen, 58455, Germany|Ludwigshafen, Rheinland-Pfalz, 67059, Germany|Mainz, Rheinland-Pfalz, 55128, Germany|Dresden, Sachsen, 01277, Germany|Dresden, Sachsen, 01307, Germany|Hoyerswerda, Sachsen, 02977, Germany|Leipzig, Sachsen, 04103, Germany|Leipzig, Sachsen, 04249, Germany|Jena, Thüringen, 07747, Germany|Berlin, 10437, Germany|Berlin, 12203, Germany|Berlin, 13187, Germany|Berlin, 13347, Germany|Hamburg, 22041, Germany|Alexandroupolis, 68100, Greece|Athens, 11527, Greece|Athens, 14455, Greece|Chaidari, 12462, Greece|Larissa, 41100, Greece|Nea Ionia, 14233, Greece|Thessaloniki, 54642, Greece|Thessaloniki, 56403, Greece|Hong Kong, Hong Kong|Shatin, Hong Kong|Sheung Wan, Hong Kong|Wong Tai Sin, Hong Kong|Baja, 6500, Hungary|Balatonfured, 8230, Hungary|Budapest, 1036, Hungary|Budapest, 1042, Hungary|Budapest, 1088, Hungary|Budapest, 1089, Hungary|Budapest, 1134, Hungary|Budapest, 1135, Hungary|Debrecen, 4031, Hungary|Eger, 3300, Hungary|Kistarcsa, 2143, Hungary|Nyiregyhaza, 4400, Hungary|Nyiregyhaza, 4405, Hungary|Papa, 8500, Hungary|Siofok, 8600, Hungary|Szeged, Hungary|Szekesfehervar, 8000, Hungary|Szentes, 6600, Hungary|Szombathely, 9700, Hungary|Veszprem, 8200, Hungary|Cork, Ireland|Dublin, D07 R2WY, Ireland|Dublin, DUBLIN 4, Ireland|Galway, Ireland|Afula, 1834111, Israel|Ashkelon, 7830604, Israel|Beer Sheva, 8410101, Israel|Hadera, 3810101, Israel|Haifa, 3109601, Israel|Holon, 5822012, Israel|Jerusalem, 9112001, Israel|Kfar Saba, 4428164, Israel|Nahariya, 2210001, Israel|Nahariya, 22100, Israel|Nazareth, 16100, Israel|Ramat Gan, 5262000, Israel|Rehovot, 7610001, Israel|Sakhnin, 3081000, Israel|Tel Aviv, 6203854, Israel|Tel Aviv, 6423906, Israel|Tel Aviv, 6905234, Israel|Tel Aviv, 6937947, Israel|Tiberias, 1528001, Israel|Zefat, 1311001, Israel|Zerifin, 7030000, Israel|Napoli, Campania, 80131, Italy|Bologna, Emilia-Romagna, 40138, Italy|Parma, Emilia-Romagna, 43126, Italy|Reggio Emilia, Emilia-Romagna, 42123, Italy|Genova, Liguria, 16011, Italy|Genova, Liguria, 16132, Italy|Bergamo, Lombardia, 24020, Italy|Bergamo, Lombardia, 24047, Italy|Bergamo, Lombardia, 24127, Italy|Milano, Lombardia, 20024, Italy|Milano, Lombardia, 20132, Italy|Milano, Lombardia, 20142, Italy|Milano, Lombardia, 20157, Italy|Monza Brianza, Lombardia, 20832, Italy|Torino, Piemonte, 10023, Italy|Torino, Piemonte, 10043, Italy|Cagliari, Sardegna, 09134, Italy|Sassari, Sardegna, 07026, Italy|Catania, Sicilia, 95124, Italy|Messina, Sicilia, 98125, Italy|Padova, Veneto, 35128, Italy|Verona, Veneto, 37126, Italy|Nagoya, Aichi, 451-8511, Japan|Nagoya, Aichi, 456-0058, Japan|Nagoya, Aichi, 457-8510, Japan|Nagoya, Aichi, 460-0001, Japan|Nagoya, Aichi, 466-8650, Japan|Toyota, Aichi, 471-8513, Japan|Funabashi, Chiba, 273-8588, Japan|Ichikawa, Chiba, 272-8516, Japan|Matsuyama, Ehime, 790-0024, Japan|Matsuyama, Ehime, 791-8026, Japan|Chikushino, Fukuoka, 818-8502, Japan|Kasuga, Fukuoka, 816-0864, Japan|Kitakyushu, Fukuoka, 800-0296, Japan|Kitakyushu, Fukuoka, 802-8555, Japan|Kitakyushu, Fukuoka, 805-8508, Japan|Kitakyushu, Fukuoka, 807-0857, Japan|Shirakawa, Fukushima, 961-0005, Japan|Ogaki, Gifu, 503-8502, Japan|Maebashi, Gunma, 371-0821, Japan|Higashihiroshima, Hiroshima, 739-0041, Japan|Asahikawa, Hokkaido, 078-8234, Japan|Hakodate, Hokkaido, 041-8680, Japan|Obihiro, Hokkaido, 080-0848, Japan|Sapporo, Hokkaido, 007-0841, Japan|Kobe, Hyogo, 650-0047, Japan|Naka, Ibaraki, 311-0113, Japan|Ushiku, Ibaraki, 300-1207, Japan|Komatsu, Ishikawa, 923-8560, Japan|Sanuki, Kagawa, 769-2393, Japan|Takamatsu, Kagawa, 760-0017, Japan|Takamatsu, Kagawa, 760-0018, Japan|Atsugi, Kanagawa, 243-0035, Japan|Fujisawa, Kanagawa, 251-0041, Japan|Kamakura, Kanagawa, 247-8533, Japan|Yokohama, Kanagawa, 235-0045, Japan|Yokohama, Kanagawa, 245-8575, Japan|Yokohama, Kanagawa, 247-8581, Japan|Tamana, Kumamoto, 865-0016, Japan|Yatsushiro, Kumamoto, 866-0824, Japan|Sasebo, Nagasaki, 857-1195, Japan|Beppu, Oita, 874-0011, Japan|Yufu, Oita, 879-5593, Japan|Nakagami-gun, Okinawa, 901-2393, Japan|Shimajiri, Okinawa, 901-0493, Japan|Suita, Osaka, 565-0862, Japan|Kawaguchi, Saitama, 332-0012, Japan|Sayama, Saitama, 350-1305, Japan|Otsu, Shiga, 520-0804, Japan|Iwata, Shizuoka, 438-8550, Japan|Oyama, Tochigi, 323-0022, Japan|Minato, Tokyo, 108-0073, Japan|Musashino, Tokyo, 180-8610, Japan|Shibuya-ku, Tokyo, 150-0002, Japan|Fukui, 910-8526, Japan|Fukui, 918-8503, Japan|Fukuoka, 811-0213, Japan|Fukuoka, 814-0180, Japan|Fukuoka, 815-8555, Japan|Kagoshima, 890-8760, Japan|Kumamoto, 861-4193, Japan|Kumamoto, 861-8520, Japan|Kumamoto, 862-0976, Japan|Nagasaki, 852-8511, Japan|Osaka, 530-0001, Japan|Osaka, 530-8480, Japan|Osaka, 543-0035, Japan|Osaka, 553-0003, Japan|Osaka, 558-8558, Japan|Saitama, 331-8577, Japan|Chuncheon Si, Gang''weondo, 0, Korea, Republic of|Wonju, Gang''weondo, 26426, Korea, Republic of|Anyang-si, Gyeonggido, 14068, Korea, Republic of|Goyang-si, Gyeonggido, 10475, Korea, Republic of|Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, 21431, Korea, Republic of|Seoul, Seoul Teugbyeolsi, 03080, Korea, Republic of|Seoul, Seoul Teugbyeolsi, 17985, Korea, Republic of|Busan, 47392, Korea, Republic of|Busan, 49241, Korea, Republic of|Daejeon, 35015, Korea, Republic of|Seoul,, 01830, Korea, Republic of|Seoul, 02841, Korea, Republic of|Seoul, 03722, Korea, Republic of|Seoul, 05278, Korea, Republic of|Seoul, 05355, Korea, Republic of|Seoul, 05505, Korea, Republic of|Seoul, 06351, Korea, Republic of|Seoul, 07061, Korea, Republic of|Seoul, 07441, Korea, Republic of|Kaunas, LT-45217, Lithuania|Kaunas, LT-48259, Lithuania|Kaunas, LT-49449, Lithuania|Klaipeda, LT-92304, Lithuania|Utena, LT-28142, Lithuania|Vilnius, LT-08661, Lithuania|Johor Bahru, 80100, Malaysia|Kelantan, 15200, Malaysia|Kelantan, Malaysia|Kuala Lumpur, 59100, Malaysia|Pahang, 25100, Malaysia|Perak, 30450, Malaysia|Perak, 32040, Malaysia|Pulau Pinang, 10450, Malaysia|Putrajaya, 62250, Malaysia|Selangor, 47000, Malaysia|Ciudad de México, Distrito Federal, 6700, Mexico|México D.F., Distrito Federal, 14080, Mexico|México, D. F., Distrito Federal, 11850, Mexico|México, D. F., Distrito Federal, 3100, Mexico|Guadalajara, Jalisco, 44600, Mexico|Guadalajara, Jalisco, 44657, Mexico|Cuernavaca, Morelos, 62250, Mexico|Queretaro, Querétaro, 76000, Mexico|San Juan del Río, Querétaro, 76800, Mexico|Culiacán, Sinaloa, 80200, Mexico|Culiacán, Sinaloa, 80230, Mexico|Mazatlán, Sinaloa, 82110, Mexico|Puerto de Veracruz, Veracruz, 91900, Mexico|Xalapa, Veracruz, 91193, Mexico|Aguascalientes, 20219, Mexico|Chihuahua, 31238, Mexico|Ciudad de México, 06726, Mexico|Alkmaar, 1815 JD, Netherlands|Almere, 1315 RA, Netherlands|Amersfoort, 3818 TZ, Netherlands|Amsterdam, 1091 AC, Netherlands|Amsterdam, 1105 AZ, Netherlands|Apeldoorn, 7334 DZ, Netherlands|Breda, 4818 CK, Netherlands|Den Haag, 2545 CH, Netherlands|Dordrecht, 3318 AT, Netherlands|Eindhoven, 5600 PD, Netherlands|Geleen, 6162 BG, Netherlands|Groningen, 9713 GZ, Netherlands|Hoogeveen, 7909 AA, Netherlands|Nieuwegein, 3435 CM, Netherlands|Zwijndrecht, 3331 LZ, Netherlands|Auckland, 2025, New Zealand|Auckland, New Zealand|Christchurch, 8011, New Zealand|Hamilton, 3204, New Zealand|Hawkes Bay, 4130, New Zealand|Palmerston North, 4414, New Zealand|Tauranga, 3110, New Zealand|Wellington, New Zealand|Hamar, 2317, Norway|Hamar, Norway|Kløfta, 2040, Norway|Kristiansand, 4604, Norway|Levanger, 7601, Norway|Oslo, 0176, Norway|Oslo, 0450, Norway|Skedsmokorset, 2020, Norway|Trondheim, 7030, Norway|Ålesund, Norway|Iloilo City, 5000, Philippines|Marikina City, Philippines|Pasig City, 1600, Philippines|Quezon City, 1102, Philippines|Quezon City, 1110, Philippines|Quezon City, 1112, Philippines|Bialystok, 15-351, Poland|Bydgoszcz, 85-079, Poland|Chojnice, 89-600, Poland|Gdansk, 80-214, Poland|Gdynia, 81-537, Poland|Katowice, 40-040, Poland|Krakow, 30-510, Poland|Krakow, 31-156, Poland|Krakow, 31-261, Poland|Krakow, 31-559, Poland|Lodz, 90-153, Poland|Lodz, 92-213, Poland|Lodz, 94-060, Poland|Lublin, 20-538, Poland|Olsztyn, 10-561, Poland|Poznan, 60-834, Poland|Rzeszów, 35-055, Poland|Skorzewo, 60-185, Poland|Szczecin, 70-111, Poland|Torun, 87-100, Poland|Warszawa, 01-868, Poland|Warszawa, Poland|Wroclaw, 51-162, Poland|Wroclaw, 51-685, Poland|Zabrze, 41-800, Poland|Covilha, Castelo Branco, 6200-251, Portugal|Loures, Lisboa, 2674-514, Portugal|Matosinhos, Porto, 4464-513, Portugal|Funchal, Região Autónoma Da Madeira, 9004-514, Portugal|Torres Novas, Santarém, 2350-754, Portugal|Setubal, Setúbal, 2900-446, Portugal|Almada, 2801-951, Portugal|Amadora, 2720-276, Portugal|Braga, 4710-243, Portugal|Faro, 8000-386, Portugal|Leiria, 2410-197, Portugal|Lisboa, 1069-166, Portugal|Lisboa, 1250-189, Portugal|Lisboa, 1449-005, Portugal|Lisboa, 1500-650, Portugal|Porto, 4099-001, Portugal|Porto, 4200-319, Portugal|Viana do Castelo, 4901-858, Portugal|Cidra, 00739, Puerto Rico|San Juan, 00909-3004, Puerto Rico|Alba-Iulia, Alba, 510053, Romania|Baia Mare, Maramures, 430222, Romania|Ploiesti, Prahova, 100179, Romania|Timisoara, Timis, 300456, Romania|Bucuresti, 010507, Romania|Bucuresti, 010627, Romania|Bucuresti, 010825, Romania|Bucuresti, 014142, Romania|Bucuresti, 020614, Romania|Bucuresti, 031818, Romania|Bucuresti, 050538, Romania|Cluj-Napoca, 400006, Romania|Galati, 800001, Romania|Iasi, 700547, Romania|Oradea, 410159, Romania|Satu Mare, 440192, Romania|Timisoara, 300736, Romania|Arkhangelsk, 163001, Russian Federation|Barnaul, 656024, Russian Federation|Chelyabinsk, 454021, Russian Federation|Irkutsk, 664079, Russian Federation|Izhevsk, 426063, Russian Federation|Kazan, 420012, Russian Federation|Kazan, 420101, Russian Federation|Kemerovo, 650002, Russian Federation|Kemerovo, 650055, Russian Federation|Kemerovo, 650066, Russian Federation|Kirov, 610014, Russian Federation|Krasnodar, 350086, Russian Federation|Krasnoyarsk, 660062, Russian Federation|Kursk, 305004, Russian Federation|Moscow, 111539, Russian Federation|Moscow, 117292, Russian Federation|Moscow, 119034, Russian Federation|Moscow, 119991, Russian Federation|Moscow, 123182, Russian Federation|Moscow, 123423, Russian Federation|Moscow, 125101, Russian Federation|Moscow, 125315, Russian Federation|Moscow, 129110, Russian Federation|Nizhny Novgorod, 603018, Russian Federation|Nizhny Novgorod, 603126, Russian Federation|Novosibirsk, 630005, Russian Federation|Novosibirsk, 630047, Russian Federation|Novosibirsk, 630089, Russian Federation|Novosibirsk, 630117, Russian Federation|Omsk, 644024, Russian Federation|Omsk, 644033, Russian Federation|Omsk, 644112, Russian Federation|Orenburg, 460040, Russian Federation|Perm, 614097, Russian Federation|Ryazan, 390026, Russian Federation|Saratov, 410030, Russian Federation|St. Petersburg, 193312, Russian Federation|St. Petersburg, 194044, Russian Federation|St. Petersburg, 194223, Russian Federation|St. Petersburg, 194354, Russian Federation|St. Petersburg, 195067, Russian Federation|St. Petersburg, 195112, Russian Federation|St. Petersburg, 195257, Russian Federation|St. Petersburg, 197762, Russian Federation|St. Petersburg, 199226, Russian Federation|Stavropol, 355030, Russian Federation|Syktyvkar, 167981, Russian Federation|Voronezh, 394018, Russian Federation|Voronezh, 394077, Russian Federation|Yaroslavl, 150003, Russian Federation|Yaroslavl, 150062, Russian Federation|Yekaterinburg, 620102, Russian Federation|Singapore, 119074, Singapore|Singapore, 169608, Singapore|Singapore, 169609, Singapore|Singapore, 529889, Singapore|Singapore, 768828, Singapore|Bardejov, 085 01, Slovakia|Nitra, 949 11, Slovakia|Rimavska Sobota, 979 01, Slovakia|Roznava, 048 01, Slovakia|Zilina, 01001, Slovakia|Port Elizabeth, Eastern Cape, 6045, South Africa|Benoni, Gauteng, 1501, South Africa|Johannesburg, Gauteng, 2198, South Africa|Lenasia South, Gauteng, 1835, South Africa|Newtown, Gauteng, 2113, South Africa|Petoria, Gauteng, South Africa|Pretoria, Gauteng, 0002, South Africa|Pretoria, Gauteng, 0181, South Africa|Soweto, Gauteng, 1818, South Africa|Durban, Kwazulu-Natal, 4030, South Africa|Isipingo Rail, Kwazulu-Natal, 4110, South Africa|Tongaat, Kwazulu-Natal, 4400, South Africa|Middelburg, Mpumalanga, 1055, South Africa|Witbank, Mpumalanga, 1035, South Africa|Cape Town, Western Cape, 7570, South Africa|Cape Town, Western Cape, 7925, South Africa|Somerset West, Western Cape, 7130, South Africa|Worcester, Western Cape, 6850, South Africa|Pretoria, 0002, South Africa|Ferrol, A Coruña, 15405, Spain|Badalona, Barcelona, 08916, Spain|Manresa, Barcelona, 08243, Spain|Sant Joan Despi, Barcelona, 08970, Spain|Jerez de la Frontera, Cádiz, 11407, Spain|Burela, Lugo, 27880, Spain|Alcalá de Henares, Madrid, 28805, Spain|Boadilla del Monte, Madrid, 28660, Spain|Getafe, Madrid, 28905, Spain|Sagunto, Valencia, 46520, Spain|A Coruña, 15006, Spain|Barcelona, 08003, Spain|Barcelona, 08023, Spain|Barcelona, 08025, Spain|Barcelona, 08907, Spain|Barcelona, 8036, Spain|Córdoba, 14004, Spain|Granada, 18012, Spain|Jaén, 23007, Spain|Madrid, 28007, Spain|Madrid, 28041, Spain|Málaga, 29010, Spain|Valencia, 46010, Spain|Valencia, 46014, Spain|Valencia, 46017, Spain|Valencia, 46026, Spain|Göteborg, 413 45, Sweden|Göteborg, 413 46, Sweden|Lund, 221 85, Sweden|Lund, 222 21, Sweden|Rättvik, 795 30, Sweden|Skövde, 541 50, Sweden|Stockholm, 113 24, Sweden|Stockholm, 114 46, Sweden|Stockholm, 141 86, Sweden|Stockholm, 182 88, Sweden|Uppsala, 751 85, Sweden|Uppsala, 752 37, Sweden|Örebro, 701 85, Sweden|Örebro, 703 62, Sweden|Liestal, Basel-Landschaft, 4410, Switzerland|Geneva, Genève, 1205, Switzerland|St. Gallen, Sankt Gallen, 1009, Switzerland|St. Gallen, Sankt Gallen, 9016, Switzerland|Olten, Solothurn, 4600, Switzerland|Frauenfeld, Thurgau, 8501, Switzerland|Lausanne, Vaud, 1011, Switzerland|Bern, 3010, Switzerland|Changhua, 50006, Taiwan|Kaohsiung, 833, Taiwan|New Taipei City, 220, Taiwan|Taichung, 40447, Taiwan|Taichung, 40705, Taiwan|Taipei, 100, Taiwan|Taipei, 110, Taiwan|Taipei, 11217, Taiwan|Taoyuan, 33305, Taiwan|Bangkok, 10400, Thailand|Bangkok, Thailand|Chiangmai, 50200, Thailand|Khon Kaen, 40002, Thailand|Ankara, Turkey|Antalya, 07058, Turkey|Edirne, 22030, Turkey|Izmir, 35540, Turkey|Kayseri, 38039, Turkey|Kocaeli, 41380, Turkey|Malatya, 44280, Turkey|Samsun, 55139, Turkey|Sivas, 58140, Turkey|Cherkasy, 18009, Ukraine|Chernivtsi, 58002, Ukraine|Dnipro, 49000, Ukraine|Dnipro, 49023, Ukraine|Ivano-Frankivsk, 76008, Ukraine|Kharkiv, 61037, Ukraine|Kharkiv, 61039, Ukraine|Kharkiv, 61058, Ukraine|Kharkiv, 61070, Ukraine|Kiev, 01021, Ukraine|Kiev, 03049, Ukraine|Kiev, 04050, Ukraine|Kiev, 04114, Ukraine|Kiev, 1601, Ukraine|Kyiv, 03037, Ukraine|Lviv, 79010, Ukraine|Mykolayiv, 54003, Ukraine|Ternopil, 46002, Ukraine|Uzhgorod, 88018, Ukraine|Vinnytsia, 21001, Ukraine|Zaporizhzhya, 69001, Ukraine|Zaporizhzhya, 69600, Ukraine|Llanelli, Carmarthenshire, SA14 8QF, United Kingdom|Leicester, Leicestershire, LE5 4PW, United Kingdom|Salford, Manchester, M6 8HD, United Kingdom|Liverpool, Merseyside, L7 8XP, United Kingdom|Northampton, Northamptonshire, NN1 5BD, United Kingdom|Carshalton, Surrey, SM5 1AA, United Kingdom|Newcastle Upon Tyne, Vale Of Glamorgan, The, NE1 4LP, United Kingdom|Chichester, West Sussex, PO19 6SE, United Kingdom|Bristol, BS10 5NB, United Kingdom|London, E1 1BB, United Kingdom|London, NW3 2QG, United Kingdom|London, SE5 9RS, United Kingdom|Manchester, M8 5RB, United Kingdom|Middlesborough, TS4 3BW, United Kingdom|Portsmouth, PO6 3LY, United Kingdom|Ha Noi, 10000, Vietnam|Ha Noi, Vietnam|Ho Chi Minh City, 70000, Vietnam|Ho Chi Minh City, 84, Vietnam|Ho Chi Minh City, Vietnam
URL: https://clinicaltrials.gov/show/NCT02540993