- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00578695
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
June 20, 2011 updated by: CardioKine Inc.
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
Study Overview
Study Type
Interventional
Enrollment (Actual)
652
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1027
- Research Site
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Buenos Aires, Argentina, 1210
- Research Site
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Buenos Aires, Argentina, 1437
- Research Site 1
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Buenos Aires, Argentina, 1605
- Research Site 1
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Buenos Aires, Argentina, 1878
- Research Site 1
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Buenos Aires, Argentina, 2900
- Research Site 1
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Buenos Aires, Argentina, 8000
- Research Site 1
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Buenos Aires, Argentina, B1708KCH
- Research Site 1
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Buenos Aires, Argentina, C1426BOR
- Hospital Militar Central H Gral. 601 "Cirujano Mayor Dr. Cosme Argerich"
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Buenos Aires, Argentina
- Hospital de Clinicas "Jose De San Martin"
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Cerrientes, Argentina
- Research Site 1
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Provincia de Buenos Aires, Argentina
- Research Site 1
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Provincia de Misiones, Argentina, 3300
- Research Site 1
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Provincia de Santa Fe, Argentina
- Research Site 1
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Tucuman, Argentina, 4000
- Research Site 1
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Buenos Aires
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San Martin, Buenos Aires, Argentina, 1650
- hospital Interzonal General de Agudos, "Eva Peron" (HIGA)
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Galvan
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Ciudad Autonomo de Buenos Aires, Galvan, Argentina, CP FWO1431
- Research Site
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Santa Fe
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Rosario, Santa Fe, Argentina, CP2000
- Research Site
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Manitoba, Canada, R2H 2A6
- Research Site 1
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New Brunswick, Canada, E2K 4P8
- Research Site 1
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Quebec, Canada, G1V 4G5
- Research Site 1
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Quebec, Canada, J6E 6J2
- Research Site 1
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Vancouver, Canada, V6Z 1Y6
- Research Site 1
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Ontario
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Kitchener, Ontario, Canada, N2N 2A8
- Research Site 1
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Ottawa, Ontario, Canada, K1Y 4W7
- Research Site 1
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Scarborough, Ontario, Canada, M1P2T7
- Research Site 1
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Toronto, Ontario, Canada, M5G 2N2
- Research Site 1
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Quebec
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Montreal, Quebec, Canada, H2W 1T8
- Research Site 1
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Montreal, Quebec, Canada, H3A 1A1
- Research Site 1
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Sherbrooke, Quebec, Canada, J1H 5N4
- Research Site 1
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St. Jerome, Quebec, Canada, J7Z 5T3
- Research Site 1
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Antofagasta, Chile, 1945
- Research Site 1
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Concepcion, Chile
- Research Site 1
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Orosno, Chile
- Research Site 1
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Puerto Montt, Chile
- Hospital De Puerto Montt
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Santiago, Chile, 0155
- Research Site
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Santiago, Chile, 3204
- Research Site 1
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Santiago, Chile
- Research Site 1
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Temuco, Chile, 115
- Research Site
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Vina del Mar, Chile, 1532
- Research Site 1
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Havlickuv Brod, Czech Republic, 580 22
- Research Site 1
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Kladno, Czech Republic, 272 59
- Research Site 1
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Kromeriz, Czech Republic, 767 55
- Research Site 1
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Liberec, Czech Republic, 460-63
- Research Site 1
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Mestec Kralove, Czech Republic, 289 03
- Research Site 1
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Ostrava, Czech Republic, 72880
- Research Site 1
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Praha, Czech Republic, 150 30
- Research Site 1
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Praha, Czech Republic, 180 81
- Research Site 1
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Praha 1, Czech Republic
- Research Site 1
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Praha 2, Czech Republic, 128 08
- Research Site 1
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Pribram, Czech Republic, 261 26
- Research Site 1
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Znojmo, Czech Republic, 669 02
- Research Site 1
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Bad Krozingen, Germany, 71989
- Research Site 1
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Bad Nauheim, Germany, 61231
- Research Site 1
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Bad Segeberg, Germany, 23795
- Research Site 1
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Berlin, Germany, 12200
- Research Site 1
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Berlin, Germany, 13353
- Research Site 1
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Bonn, Germany, 53105
- Research Site 1
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Coburg, Germany, 96450
- Research Site 1
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Dresden, Germany, 01307
- Research Site 1
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Gottingen, Germany, 37075
- Research Site 1
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Greifswald, Germany, 17475
- Research Site 1
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Hamburg, Germany, 20246
- Research Site 1
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Hannover, Germany, 30167
- Research Site 1
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Hannover, Germany, 30625
- Research Site 1
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Jena, Germany, 07747
- Research Site 1
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Karisbad, Germany, 76307
- Research Site 1
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Konstanz, Germany, 78464
- Research Site 1
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Leipzig, Germany, 04289
- Research Site 1
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Regensburg, Germany, 93053
- Research Site 1
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Regensburg, Germany, 94053
- Research Site 1
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Rostock, Germany, 18057
- Research Site 1
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Soest, Germany, 59494
- Research Site 1
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Bikaner, India, 334001
- Research Site
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Coimbatore, India
- Research Site 1
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Madhya Pradesh, India
- Research Site 1
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Maharashtra, India
- Research Site 1
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Maharastra, India
- Research Site 1
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Mumbai, India, 400 007
- Research Site
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New Delhi, India, 110076
- Research Site
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New Delhi, India
- Sir Ganga Ram Hospital
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New Delhi, India, 110025
- Research Site
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Rajasthan, India
- Research Site 1
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Tamul Nadu, India, 600116
- Sri Ramachandra Medical College of research Institute
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Andhra Pradesh
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Secunderabad, Andhra Pradesh, India, 500 003
- Research Site
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Chennai
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Mogappair, Chennai, India, 600037
- Research Site
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Gujarat
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Naranpura, Gujarat, India, 380014
- Research Site
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Hyderabad
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Panjagutta, Hyderabad, India, 500082
- Research Site
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Karnataka
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Bangalore, Karnataka, India, 560 054
- Research Site
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Bangalore, Karnataka, India, 560 034
- Research Site
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Bangalore, Karnataka, India, 560052
- Research Site
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Nashik
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College Road, Nashik, India, 422 005
- Research Site
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Shalimar, Nashik, India, 422 002
- Shree Saibaba Heart Institute and Research Centre
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Be'er-Sheva, Israel, 84101
- Research Site 1
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Haifa, Israel, 31048
- Research Site
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Haifa, Israel, 31048
- Research Site 1
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Holon, Israel, 58100
- Research Site 1
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Jerusalem, Israel, 91120
- Research Site
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Jerusalem, Israel, 91004
- Research Site 1
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Jerusalem, Israel, 91240
- Research Site 1
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Petah Tkva, Israel
- Research Site 1
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Safed, Israel, 13100
- Research Site 1
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Tel Aviv, Israel, 64239
- Research Site 1
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Bologna, Italy, 40138
- Research Site 1
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Brescia, Italy, 25123
- Research Site
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Cecina, Italy, 57023
- Research Site 1
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Cortina, Italy, 52044
- Research Site 1
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Genova, Italy, 16132
- Research Site 1
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Milano, Italy, 20132
- Research Site 1
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Novara, Italy, 28100
- Research Site 1
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Parma, Italy, 43100
- Research Site 1
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Pavia, Italy, 27100
- Research Site 1
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Piacenza, Italy, 29100
- Research Site 1
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Ravenna, Italy
- Research Site 1
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Roma, Italy, 00161
- Research Site 1
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Torino, Italy, 10126
- Azienda Ospedaliero-Universitaria "San Giovanni Battista di Torino" Struttura Complessa Cardiologia 1
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Torino, Italy, 10126
- Research Site 1
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Bydgoszcz, Poland, 85-168
- Research Site 1
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Gdynia, Poland, 81-519
- Research Site 1
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Kielce, Poland, 25-736
- Research Site
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Krakow, Poland, 31-121
- Research Site 1
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Krakow, Poland, 31-501
- Research Site 2
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Krakow, Poland, 31-913
- Research Site
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Lubartow, Poland, 21-100
- Research Site
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Ostroleka, Poland, 07-410
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej
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Ostrowiec Swietokrzyski, Poland, 27-400
- Research Site 1
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Pabianice, Poland, 95-200
- Research Site
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Piotrkow Trybunalski, Poland, 97-300
- Samodzielnl Szpital Wojewodzki
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Radom, Poland, 26-617
- Wojewodzki Szpital Specjalistczny w Radomiu, Oddzial Kardiologil
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Sieradz, Poland, 98-200
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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Starogard Gdanski, Poland
- Research Site
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Torun, Poland, 87-100
- Research Site 1
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Warszawa, Poland, 04-141
- Wojskowy Instytut Medyczny
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Warszawa, Poland, 00-909
- Research Site 1
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Warszawa, Poland, 01-211
- Research Site 1
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Warszawa, Poland, 02-005
- Research Site 1
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Warszawa, Poland, 02-507
- Research Site 1
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Warszawa, Poland, 02-637
- Research Site 1
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Warszawa, Poland, 04-749
- Research Site 1
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Wroclaw, Poland, 50-367
- Research Site 1
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Wroclaw, Poland, 51-124
- Research Site 1
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Nysa
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Curie 1, Nysa, Poland, 48-300
- Research Site
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Brasov, Romania, 500152
- Research Site
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Bucharest, Romania, 014461
- Research Site 1
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Bucharest, Romania, 030572
- Research Site 1
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Tg Mures, Romania, 540136
- Research Site 1
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Timisoara, Romania, 300310
- Research Site 1
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Saint Petersburg, Russian Federation, 191187
- Research Site 1
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Moscow
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Lenskaya, Moscow, Russian Federation, 129327
- Research Site 1
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Russia
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Moscow, Russia, Russian Federation, 109240
- Research Site 1
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Moscow, Russia, Russian Federation, 111020
- Research Site 1
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Moscow, Russia, Russian Federation, 115487
- Research Site 1
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Moscow, Russia, Russian Federation, 115516
- Research Site 1
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Moscow, Russia, Russian Federation, 119192
- Research Site 1
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Moscow, Russia, Russian Federation, 119620
- Research Site 1
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Moscow, Russia, Russian Federation, 121359
- Research Site 1
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Moscow, Russia, Russian Federation, 123423
- Research Site 1
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Moscow, Russia, Russian Federation, 125284
- Research Site 1
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Moscow, Russia, Russian Federation, 127018
- Research Site 1
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Moscow, Russia, Russian Federation, 127473
- Research Site 1
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Moscow, Russia, Russian Federation, 129110
- Research Site
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Moscow, Russia, Russian Federation, 129301
- Research Site 1
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Moscow, Russia, Russian Federation, 129336
- Research Site 1
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Moscow, Russia, Russian Federation
- Research Site 1
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Saint-Petersburg, Russia, Russian Federation, 192242
- Research Site 1
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Saint-Petersburg, Russia, Russian Federation, 194156
- Research Site 1
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Saint-Petersburg, Russia, Russian Federation, 196247
- Research Site 1
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Saint-Petersburg, Russia, Russian Federation, 197110
- Research Site 1
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Saint-Petersburg, Russia, Russian Federation, 199106
- Research Site 1
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Saint-Petersburg
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L'va Tolstogo, Saint-Petersburg, Russian Federation, 197022
- Research Site 1
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Solidamosty, Saint-Petersburg, Russian Federation, 193312
- Research Site 1
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Bratislava, Slovakia, 826 06
- Research Site 1
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Nitra, Slovakia, 949 01
- Research Site 1
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Trencin, Slovakia, 91171
- Interna klinika, Fakultna nemocnica Trencin
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Barcelona, Spain, 08036
- Research Site 1
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Barcelona, Spain, 08003
- Research Site 1
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Cordoba, Spain, 14004
- Research Site 1
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Madrid, Spain, 28007
- Research Site 1
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Malaga, Spain, 29010
- Hospital Univeritario Virgen de la Victoria Servicio de Cardiologia
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Malaga, Spain, 29010
- Research Site 1
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Santiago de Compostela, Spain, 15706
- Research Site 1
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Vigo, Spain, 36200
- Research Site 1
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Geneva, Switzerland, 1217
- Research Site
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Alabama
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Birmingham, Alabama, United States, 35211
- Research Site 1
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Birmingham, Alabama, United States, 35294
- Research Site 1
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Mobile, Alabama, United States, 36604
- Research Site 1
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California
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Bakersfield, California, United States, 93308
- Research Site 1
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Banning, California, United States, 92220
- Research Site 1
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Glendale, California, United States, 91204
- Research Site
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Glendale, California, United States, 91204
- Research Site 1
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Los Angeles, California, United States, 90048
- Research Site 1
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Mission Viejo, California, United States, 92691
- Research Site 1
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Roseville, California, United States, 95661
- Research Site 1
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San Diego, California, United States, 92103
- Research Site 1
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San Diego, California, United States, 92161
- Research Site 1
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Colorado
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Aurora, Colorado, United States, 80045
- Research Site 1
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Delaware
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Newark, Delaware, United States, 19718
- Research Site 1
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Research Site 1
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Florida
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Bay Pines, Florida, United States, 33744
- Research Site 1
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Ft. Lauderdale, Florida, United States, 33316
- Research Site 1
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Gainesville, Florida, United States, 32610
- Research Site 1
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Jacksonville, Florida, United States, 32209
- Research Site 1
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Jacksonville, Florida, United States, 32216
- Research Site 1
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Jacksonville, Florida, United States, 32224
- Research Site 1
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Lakeland, Florida, United States, 33805
- Research Site 1
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Miami, Florida, United States, 33136
- Research Site 1
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Port Charlotte, Florida, United States, 33952
- Research Site 1
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Tampa, Florida, United States, 33606
- Research Site 1
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Tampa, Florida, United States, 33613
- Research Site 1
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Georgia
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Atlanta, Georgia, United States, 30322
- Research Site 1
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Illinois
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Bannockburn, Illinois, United States, 60015
- Research Site 1
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Chicago, Illinois, United States, 60612
- Research Site 1
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Maywood, Illinois, United States, 60153
- Research Site 1
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Normal, Illinois, United States, 61761
- Research Site 1
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North Chicago, Illinois, United States
- Research Site 1
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Oak Lawn, Illinois, United States, 60453
- Research Site 1
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Peoria, Illinois, United States, 61606
- Research Site 1
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Peoria, Illinois, United States, 61614
- Research Site 1
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Indiana
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Munster, Indiana, United States, 46321
- Research Site 1
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Iowa
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Iowa City, Iowa, United States, 522442
- University of Iowa Hospitals and Clinics
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Iowa City, Iowa, United States, 52245
- Research Site 1
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Kentucky
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Louisville, Kentucky, United States, 40202
- Research Site 1
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Louisville, Kentucky, United States, 40207
- Research Site 1
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Research Site 1
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Slidell, Louisiana, United States, 70458
- Research Site 1
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Maryland
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Baltimore, Maryland, United States, 21229
- Research Site 1
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Research Site 1
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Burlington, Massachusetts, United States, 01805
- Research Site 1
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Michigan
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Detroit, Michigan, United States, 48201
- Research Site
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Detroit, Michigan, United States, 48202
- Research Site 1
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Petoskey, Michigan, United States, 49770
- Northern Michigan Hospital
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Petoskey, Michigan, United States, 49770
- Research Site 1
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Traverse City, Michigan, United States, 49684
- Research Site 1
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Minnesota
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Duluth, Minnesota, United States, 55805
- Research Site 1
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Missouri
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St. Louis, Missouri, United States, 63104
- Research Site 1
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St. Louis, Missouri, United States, 63110
- Research Site 1
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Research Site 1
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New Hampshire
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Concord, New Hampshire, United States, 03301
- Research Site 1
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Research Site 1
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Livingston, New Jersey, United States, 07039
- Siant Barnabas Medical Center
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Morristown, New Jersey, United States, 07982
- Research Site 1
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Newark, New Jersey, United States, 07112
- Research Site 1
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Orange, New Jersey, United States, 07052
- Research Site 1
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Paramus, New Jersey, United States, 07652
- Research Site 1
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New York
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Bronx, New York, United States, 10461
- Research Site 1
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Jamaica, New York, United States, 11418
- Research Site 1
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New York, New York, United States, 10029
- Research Site
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Northport, New York, United States, 11768
- Research Site 1
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Stony Brook, New York, United States, 11794
- Research Site 1
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Valhalla, New York, United States, 10595
- Research Site 1
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Research Site 1
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Ohio
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Cincinnati, Ohio, United States, 45267
- Research Site 1
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Columbus, Ohio, United States, 43205
- Research Site 1
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Fairfield, Ohio, United States, 45014
- Research Site
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Fairfield, Ohio, United States, 45014
- Research Site 1
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Middletown, Ohio, United States, 45042
- Research Site 1
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Toledo, Ohio, United States, 43614
- Research Site 1
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Research Site 1
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Oklahoma City, Oklahoma, United States, 73120
- Research Site 2
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Tulsa, Oklahoma, United States, 74133
- Research Site 1
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Oregon
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Springfield, Oregon, United States, 97477
- Research Site 1
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- Research Site 1
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Camp Hill, Pennsylvania, United States, 17011
- Research Site 1
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Danville, Pennsylvania, United States, 17822
- Research Site 1
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Pittsburg, Pennsylvania, United States, 15212
- Research Site 1
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Sayre, Pennsylvania, United States, 18840
- Research Site1
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Sellersville, Pennsylvania, United States, 18960
- Research Site 1
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Research Site 1
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Germantown, Tennessee, United States, 38138
- Research Site 1
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Nashville, Tennessee, United States, 37208
- Research Site 1
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Texas
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Amarillo, Texas, United States, 79106
- Research Site 1
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Dallas, Texas, United States, 75230
- Research Site 1
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Dallas, Texas, United States, 75231
- Research Site 1
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Galveston, Texas, United States, 77555
- Research Site 1
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Houston, Texas, United States, 77030
- Research Site 1
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Houston, Texas, United States, 77074
- Research Site 1
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Lubbock, Texas, United States, 79410
- Research Site 1
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Temple, Texas, United States, 76508
- Research Site 1
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Tyler, Texas, United States, 75701
- Research Site 1
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Virginia
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Chesapeake, Virginia, United States, 23320
- Research Site 1
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Richmond, Virginia, United States, 232225
- Research Site 2
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Richmond, Virginia, United States, 23249
- Research Site 1
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Washington
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Seattle, Washington, United States, 98195
- Research Site 1
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Wisconsin
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Beloit, Wisconsin, United States, 53511
- Research Site 1
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Madison, Wisconsin, United States, 53792
- Research Site 1
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Oral Capsule
|
EXPERIMENTAL: Active
Lixivaptan
|
Oral Capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (ESTIMATE)
December 21, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
June 28, 2011
Last Update Submitted That Met QC Criteria
June 20, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CK-LX3401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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-
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States