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Clinical Trial Details

Trial ID: L2298
Source ID: NCT01137474
Associated Drug: Dapagliflozin
Title: A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01137474/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Placebo-matching dapagliflozin
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12, Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation., From Baseline to Week 12|Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12, HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation., From Baseline to Week 12 | Secondary: Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward), Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them., From Baseline to Week 12|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12, All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis., From Baseline to Week 12|Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]), Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them., From Baseline to Week 12|Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12, Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis., From Baseline to Week 12
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2996
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date: 2013-02
Results First Posted: 2014-05-01
Last Update Posted: 2017-01-26
Locations: University Of Alabama At Birmingham, Birmingham, Alabama, 35294, United States|Horizon Research Group, Inc., Mobile, Alabama, 36608, United States|Iicr, Inc. (International Institute Of Clinical Research), Ozark, Alabama, 36360, United States|Hope Research Institute, Phoenix, Arizona, 85050, United States|43rd Medical Associates, Phoenix, Arizona, 85051, United States|Central Phoenix Medical Clinic, Llc, Tempe, Arizona, 85282, United States|Clinical Research Advantage/Desert Clinical Research, Tempe, Arizona, 85282, United States|Visions Clinical Research - Tucson, Tucson, Arizona, 85712, United States|Eclipse Clinical Research, Tucson, Arizona, 85745, United States|Aureus Research, Inc., Little Rock, Arkansas, 72211, United States|Preferred Research Partners, Inc., Little Rock, Arkansas, 72211, United States|Orange County Research Institute, Anaheim, California, 92801, United States|Cmp Research, Anaheim, California, 92805, United States|Med Center, Carmichael, California, 95608, United States|Catalina Research Institute, Llc, Chino, California, 91710, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Marin Endocrine Care & Research, Inc., Greenbrae, California, 94904, United States|Del Rosario Medical Clinic, Inc., Huntington Park, California, 90255, United States|Time Clinical Research Inc., Huntington Park, California, 90255, United States|Marina Raikhel, M.D., F.A.A.F.P, Lomita, California, 90717, United States|Clinica Medica San Miguel, Los Angeles, California, 90015, United States|American Institute Of Research, Los Angeles, California, 90017, United States|Randall G. Shue, D.O., Los Angeles, California, 90023, United States|National Research Inst, Los Angeles, California, 90057, United States|Quest Diagnostics West Hills, Los Angeles, California, 90057, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Valley Clinical Trials, Northridge, California, 91325, United States|Lucita M. Cruz,Md.,Inc., Norwalk, California, 90650, United States|Sds Clinical Trials, Orange, California, 92868, United States|Integrated Research Group, Inc., Riverside, California, 92506, United States|Quality Control Research, Inc, Sacramento, California, 95842, United States|Crest Clinical Trials, Inc., Santa Ana, California, 92701, United States|Orrin M. Troum, Md And Medical Associates, Santa Monica, California, 90404, United States|Orange County Research Center, Tustin, California, 92780, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Infosphere Clinical Research, Inc., West Hills, California, 91307, United States|Aurora Family Medicine, P.C., Aurora, Colorado, 80012, United States|Horizons Clinical Research Center, Llc, Denver, Colorado, 80220, United States|Chase Medical Research, Llc, Waterbury, Connecticut, 06708, United States|Zasa Clinical Research, Boynton Beach, Florida, 33472, United States|Bradenton Research Center, Inc., Bradenton, Florida, 34205, United States|Meridien Research, Brooksville, Florida, 34601, United States|Family Care Associates Of Nw Fl, Chipley, Florida, 32428, United States|Innovative Research Of West Florida, Inc, Clearwater, Florida, 33756, United States|Clinical Research Of South Florida, Coral Gables, Florida, 33134, United States|Avail Clinical Research, Llc, Deland, Florida, 32720, United States|In Vivo Clinical Research, Doral, Florida, 33166, United States|Palm Springs Research Institute, Hialeah, Florida, 33012, United States|The Community Research Of South Florida, Hialeah, Florida, 33016, United States|Newphase Clinical Trials, Inc., Miami Beach, Florida, 33140, United States|Ocean Blue Medical Research Center, Inc., Miami Springs, Florida, 33166, United States|San Marcus Research Clinic, Inc., Miami, Florida, 33015, United States|Flcri Global Research, Llc, Miami, Florida, 33125, United States|International Research Associates, Llc, Miami, Florida, 33125, United States|Clinical Research Of Miami, Inc., Miami, Florida, 33126, United States|Apf Research, Llc, Miami, Florida, 33135, United States|Community Research Foundation, Inc., Miami, Florida, 33155, United States|Medical Research Marseilles, Miami, Florida, 33155, United States|Baptist Diabetes Associates, Pa, Miami, Florida, 33156, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Compass Research, Llc, Orlando, Florida, 32806, United States|Florida Institute For Clinical Research, Llc, Orlando, Florida, 32822, United States|South Miami Clinical Research, Llc, South Miami, Florida, 33143, United States|Meridien Research, St Petersburg, Florida, 33709, United States|Meridien Research, Tampa, Florida, 33606, United States|Perimeter Institute For Clinical Research, Atlanta, Georgia, 30338, United States|Bainbridge Medical Associates, Bainbridge, Georgia, 39819, United States|River Birch Research Alliance, Llc, Blue Ridge, Georgia, 30513, United States|In-Quest Medical Research, Llc, Duluth, Georgia, 30096, United States|Middle Georgia Clinical Research Center, Llc, Perry, Georgia, 31069, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|James R. Herron, Md, Ltd, Chicago, Illinois, 60610, United States|So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc, O?Fallon, Illinois, 62269, United States|Springfield Diabetes And Endocrine Center, Springfield, Illinois, 62704, United States|American Health Network Of Indiana Llc, Avon, Indiana, 46123, United States|Investigators Research Group, Llc, Brownsburg, Indiana, 46112, United States|American Health Network Of In Llc, Franklin, Indiana, 46131, United States|Laporte County Institute For Clinical Research, Inc., Michigan City, Indiana, 46360, United States|American Health Network Of In Llc, Muncie, Indiana, 47304, United States|Medical Development Centers, Llc, Baton Rouge, Louisiana, 70808, United States|Crescent City Clinical Research Center, Metairie, Louisiana, 70006, United States|Acadia Clinical Research, Llc, Bangor, Maine, 04401, United States|Alternative Primary Care, Silver Spring, Maryland, 20910, United States|Neurocare, Inc., Brookline, Massachusetts, 02446, United States|Genesis Clinical Research, Llc, Fall River, Massachusetts, 02720, United States|Hci-Metromedic Walk-In Medical Office, New Bedford, Massachusetts, 02740, United States|Atlantic Clinical Trials, Llc, Watertown, Massachusetts, 02472, United States|Providence Park Clinical Research, Novi, Michigan, 48374, United States|The Center For Clinical Trials, Biloxi, Mississippi, 39531, United States|Phillips Medical Services, Pllc, Jackson, Mississippi, 39209, United States|Jackson Clinic, Rolling Fork, Mississippi, 39159, United States|Jefferson City Medical Group, Jefferson City, Missouri, 65109, United States|St. Louis Center For Clinical Research, St. Louis, Missouri, 63128, United States|Kcumb Dybedal Clinical Research Center, Kansas City, Montana, 64106, United States|Clin Research Advantage, Inc. James Meli, Do Family Pracice, Henderson, Nevada, 89014, United States|Office Of Ted Thorp, Md, Las Vegas, Nevada, 89102, United States|Independent Clinical Researchers@ Wolfson Medical Center, Las Vegas, Nevada, 89103, United States|Clinical Research Advantage, Inc., Las Vegas, Nevada, 89128, United States|Palm Medical Research Center, Las Vegas, Nevada, 89148, United States|Joslin Diabetes Center Affiliate Of Snhmc, Nashua, New Hampshire, 03063, United States|Central Jersey Medical Research Center, Elizabeth, New Jersey, 07202, United States|Premier Research, Trenton, New Jersey, 08611, United States|Medex Healthcare Research, Inc., New York, New York, 10022, United States|Digiovanna Institute For Medical Education & Research, North Massapequa, New York, 11758, United States|Southgate Medical Group, West Seneca, New York, 14224, United States|Barat Research Group, Inc., Charlotte, North Carolina, 28262, United States|Pharmquest, Greensboro, North Carolina, 27408, United States|Burke Primary Care, Morganton, North Carolina, 28655, United States|Pmg Research Of Wilmington Llc, Wilmington, North Carolina, 28401, United States|Lillestol Research, Fargo, North Dakota, 58103, United States|Community Health Care, Inc., Canal Fulton, Ohio, 44614, United States|Community Research, Cincinnati, Ohio, 45227, United States|Cleveland Sleep Research Center, Middleburg Heights, Ohio, 44130, United States|Clinical Research Source, Inc, Perrysburg, Ohio, 43551, United States|Integris Family Care Central, Oklahoma City, Oklahoma, 73112, United States|Sooner Clinical Research, Oklahoma City, Oklahoma, 73112, United States|Integris Family Care Yukon, Yukon, Oklahoma, 73099, United States|Willamette Valley Clinical Studies, Eugene, Oregon, 97404, United States|Fanno Creek Clinic, Portland, Oregon, 97219, United States|Southeastern Pa Medical Institute, Broomall, Pennsylvania, 19008, United States|Abington Memorial Hos/Feasterville Family Health Care Center, Feasterville Trevose, Pennsylvania, 19053, United States|The Clinical Trial Center, Llc, Jenkintown, Pennsylvania, 19046, United States|Arcuri Clinical Research Llc, Philadelphia, Pennsylvania, 19142, United States|Philadelphia Health Associates - Adult Medicine, Philadelphia, Pennsylvania, 19146, United States|Banksville Medical Pc, Pittsburgh, Pennsylvania, 15216, United States|Research Across America, Reading, Pennsylvania, 19606, United States|Pish Medical Associates, Uniontown, Pennsylvania, 15401, United States|Greater Providence Clinical Research, Llc, Warwick, Rhode Island, 02888, United States|Southeastern Research Associates, Inc., Anderson, South Carolina, 29621, United States|Southeastern Research Associates, Inc., Greenville, South Carolina, 29605, United States|Hillcrest Clinical Reseach, Llc, Simpsonville, South Carolina, 29681, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|Chattanooga Research & Medicine, Pllc, Chattanooga, Tennessee, 37404, United States|Complete Family Care Of Knoxville, Pllc, Knoxville, Tennessee, 37923, United States|Premier Internal Medicine, Memphis, Tennessee, 38119, United States|Arlington Family Research Center, Inc., Arlington, Texas, 76012, United States|Krk Medical Research, Dallas, Texas, 75230, United States|Research Institute Of Dallas, Dallas, Texas, 75231, United States|Internal Medicine Clinical Research, Dallas, Texas, 75235, United States|Renaissance Clinical Research And Hypertension Pllc, Dallas, Texas, 75235, United States|Sergio F. Rovner, M.D., El Paso, Texas, 79925, United States|Mercury Clinical Research, Houston, Texas, 77036, United States|Southwest Clinical Trials, Houston, Texas, 77074, United States|Excel Clinical Research, Llc, Houston, Texas, 77081, United States|Lone Star Clinical Research, Houston, Texas, 77088, United States|Hill Country Medical Associates, New Braunfels, Texas, 78130, United States|North Hills Medical Research, Inc., North Richland Hills, Texas, 76180, United States|Med-Olam Clinical Research, Pasadena, Texas, 77504, United States|Lisa E. Medwedeff, Md, Pa, Plano, Texas, 75024, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Abbott Clinical Research Group, Inc., San Antonio, Texas, 78224, United States|Covenant Clinical Research, Pa, San Antonio, Texas, 78229, United States|Breco Research, Ltd, Sugarland, Texas, 77479, United States|Pioneer Research Solutions, Inc., Sugarland, Texas, 77479, United States|Exodus Healthcare Network, Magna, Utah, 84044, United States|Wasatch Endocrinology And Diabetes Specialists, Salt Lake City, Utah, 84102, United States|Wasatch Clinical Research, Salt Lake City, Utah, 84107, United States|Millennium Clinical Trials Llc, Arlington, Virginia, 22203, United States|Burke Internal Medicine And Research, Burke, Virginia, 22015, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Hampton Roads Center For Clinical Research, Inc., Suffolk, Virginia, 23435, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23454, United States|Sound Medical Research, Port Orchard, Washington, 98366, United States|Local Institution, Kelowona, British Columbia, V1Y 3G8, Canada|Local Institution, Victoria, British Columbia, V8V 3N7, Canada|Local Institution, Brampton, Ontario, L6T 0G1, Canada|Local Institution, Granby, Quebec, J2G 8Z9, Canada|Local Institution, Montreal, Quebec, H2R 1V6, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 3H3, Canada|Local Institution, Medellin, Antioquia, 0000, Colombia|Local Institution, Bogota, Cundinamarca, 0000, Colombia|Local Institution, Armenia, Quindio, 0000, Colombia|Local Institution, Cali, Valle, 0000, Colombia|Local Institution, Barranquilla, 0000, Colombia|Local Institution, Barranquilla, Colombia|Local Institution, Bogota, 0000, Colombia|Local Institution, Beroun, 266 01, Czech Republic|Local Institution, Cheb, 350 02, Czech Republic|Local Institution, Havirov, 736 01, Czech Republic|Local Institution, Liberec, 460 01, Czech Republic|Local Institution, Ostrava, 702 00, Czech Republic|Local Institution, Prague 1, 116 94, Czech Republic|Local Institution, Praha 4, 149 00, Czech Republic|Local Institution, Copenhagen, 2300, Denmark|Local Institution, Copenhagen, 2400, Denmark|Local Institution, Frederiksberg, DK-2000, Denmark|Local Institution, Slagelse, 4200, Denmark|Local Institution, Kokkola, 67100, Finland|Local Institution, Oulu, 90100, Finland|Local Institution, Aschaffenburg, Bavaria, 63739, Germany|Local Institution, Vellmar, Hessen, 34246, Germany|Local Institution, Duisburg, Nordrhein-Westfalen, 47051, Germany|Local Institution, Bad Kreuznach, 55545, Germany|Local Institution, Berlin, 10787, Germany|Local Institution, Karlsruhe, 76199, Germany|Local Institution, Kothen, 06366, Germany|Local Institution, Kronshagen, 24119, Germany|Local Institution, Langenfeld, 40764, Germany|Local Institution, Lueneburg, 21339, Germany|Local Institution, Magdeburg, 39112, Germany|Local Institution, Mainz, 55116, Germany|Local Institution, Mannheim, 68161, Germany|Local Institution, Pirna, 01796, Germany|Local Institution, Saarbruecken, 66121, Germany|Local Institution, Gyongyos, Heves, 3200, Hungary|Local Institution, Eger, 3300, Hungary|Local Institution, Hatvan, 3000, Hungary|Local Institution, Miskolc, 3530, Hungary|Local Institution, Nagykanizsa, 8800, Hungary|Local Institution, Nyiregyhaza, 4400, Hungary|Local Institution, Satoraljaujhely, 3980, Hungary|Local Institution, Sopron, 9400, Hungary|Local Institution, Szeged, 6720, Hungary|Local Institution, Szekszard, H-7100, Hungary|Local Institution, Szentes, 6600, Hungary|Local Institution, Hyderabad, Andhra Pradesh, 500 034, India|Local Institution, Vijayawada, Andhra Pradesh, 520008, India|Local Institution, New Delhi, Delhi, 110070, India|Local Institution, Bangalore, Karnataka, 560 043, India|Local Institution, Bangalore, Karnataka, 560043, India|Local Institution, Belgaum, Karnatka, 590010, India|Local Institution, Indore, Madhya Pradesh, 452010, India|Local Institution, Nagpur, Maharashtra, 440010, India|Local Institution, Nagpur, Maharashtra, 440012, India|Local Institution, Nagpur, Maharashtra, 440033, India|Local Institution, Delhi, New Delhi, 110007, India|Local Institution, Jaipur, Rajasthan, 202023, India|Local Institution, Jaipur, Rajasthan, 302 001, India|Local Institution, Jaipur, Rajasthan, 302004, India|Local Institution, Coimbatore, Tamil Nadu, 641018, India|Local Institution, Madurai, Tamilnadu, 625020, India|Local Institution, Bangalore, 560092, India|Local Institution, Hyderabad, 500063, India|Local Institution, Manipal, 576104, India|Local Institution, Nagpur, 440012, India|Local Institution, Torreon, Coahuila, 27000, Mexico|Local Institution, Del. Benito Juarez, Distrito Federal, 03100, Mexico|Local Institution, Mexico City, Distrito Federal, 07760, Mexico|Local Institution, Mexico, Df, Distrito Federal, 06700, Mexico|Local Institution, Tlalpan, Distrito Federal, 14000, Mexico|Local Institution, Guadalajara, Jalisco, 44100, Mexico|Local Institution, Guadalajara, Jalisco, 44600, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Cuautla, Morelos, 62744, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Culiacan, Sinaloa, 80020, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Chihuahua, 31217, Mexico|Local Institution, Durango, 34000, Mexico|Local Institution, Guadalajara, 44680, Mexico|Local Institution, Puebla, 72000, Mexico|Local Institution, Queretaro, 76000, Mexico|Local Institution, Veracruz, 91910, Mexico|Local Institution, Chiclayo, Lambayeque, Peru|Local Institution, Lince, Lima, LIMA14, Peru|Local Institution, Arequipa, 54, Peru|Local Institution, Arequipa, Peru|Local Institution, Cusco, Peru|Local Institution, Ica, ICA01, Peru|Local Institution, Lima, 17, Peru|Local Institution, Lima, LIMA 10, Peru|Local Institution, Lima, LIMA 11, Peru|Local Institution, Lima, LIMA 31, Peru|Local Institution, Lima, LIMA 33, Peru|Local Institution, Piura, Peru|Local Institution, Bialystok, 15-404, Poland|Local Institution, Bydgoszcz, 85-822, Poland|Local Institution, Chrzanow, 32-500, Poland|Local Institution, Gdansk, 80-847, Poland|Local Institution, Gdynia, 80-384, Poland|Local Institution, Golub-Dobrzyn, 87-400, Poland|Local Institution, Kamieniec Zabkowicki, 57-230, Poland|Local Institution, Katowice, 40-748, Poland|Local Institution, Krakow, 30-015, Poland|Local Institution, Krakow, 31-159, Poland|Local Institution, Krakow, 31-949, Poland|Local Institution, Lodz, 90-242, Poland|Local Institution, Lodz, 91-078, Poland|Local Institution, Lodz, 92-003, Poland|Local Institution, Ostroda, 14-100, Poland|Local Institution, Poznan, 61-251, Poland|Local Institution, Szczecin, 70-506, Poland|Local Institution, Warsaw, 01-231, Poland|Local Institution, Warsaw, 02-097, Poland|Local Institution, Warszawa, 01-868, Poland|Local Institution, Warszawa, 02-507, Poland|Local Institution, Warszawa, 02-679, Poland|Local Institution, Warszawa, 03-580, Poland|Local Institution, Wroc#Aw, 50-088, Poland|Local Institution, WrocB Aw, 50-349, Poland|Local Institution, Zamosc, 22-400, Poland|Local Institution, Cidra, 00739, Puerto Rico|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, San Juan, 00918, Puerto Rico|Local Institution, Oradea, Bihor, 410169, Romania|Local Institution, Oradea, Jud. Bihor, 410469, Romania|Local Institution, Timisoara, Jud. Timis, 300125, Romania|Local Institution, Targu Mures, Mures, 540098, Romania|Local Institution, Targu Mures, Mures, 540142, Romania|Local Institution, Ploiesti, Prahova, 100163, Romania|Local Institution, Ploiesti, Prahova, 100342, Romania|Local Institution, Timisoara, Timis, 300456, Romania|Local Institution, Bucuresti, 010496, Romania|Local Institution, Bucuresti, 011478, Romania|Local Institution, Bucuresti, 020359, Romania|Local Institution, Bucuresti, 020475, Romania|Local Institution, Satu Mare, 440055, Romania|Local Institution, Sibiu, 550245, Romania|Local Institution, Sibiu, 550371, Romania|Local Institution, Dzerzhinskiy, 140091, Russian Federation|Local Institution, Krasnoyarsk, 660022, Russian Federation|Local Institution, Moscow, 115093, Russian Federation|Local Institution, Moscow, 119992, Russian Federation|Local Institution, Moscow, 125367, Russian Federation|Local Institution, Novosibirsk, 630076, Russian Federation|Local Institution, Saint Petersburg, 197022, Russian Federation|Local Institution, Saratov, 410028, Russian Federation|Local Institution, Smolensk, 214018, Russian Federation|Local Institution, St. Petersburg, 191119, Russian Federation|Local Institution, St.Petersburg, 195112, Russian Federation|Local Institution, Yaroslavl, 150003, Russian Federation|Local Institution, Yaroslavl, 150062, Russian Federation|Local Institution, Yaroslav, 150062, Russian Federation|Local Institution, Santiago De Compostela, A Coruna, 15706, Spain|Local Institution, Barcelona, 08036, Spain|Local Institution, La Roca Del Valles, 08430, Spain|Local Institution, Peralada, 17491, Spain
URL: https://clinicaltrials.gov/show/NCT01137474