- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02433366
Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Dobritch, Bulgarien
- Boehringer Ingelheim Investigational Site 81
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Gabrovo, Bulgarien
- Boehringer Ingelheim Investigational Site 84
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Montana, Bulgarien
- Boehringer Ingelheim Investigational Site 79
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Plovdiv, Bulgarien
- Boehringer Ingelheim Investigational Site 85
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Shumen, Bulgarien
- Boehringer Ingelheim Investigational Site 80
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Sliven, Bulgarien
- Boehringer Ingelheim Investigational Site 86
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Sofia, Bulgarien
- Boehringer Ingelheim Investigational Site 87
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Stara Zagora, Bulgarien
- Boehringer Ingelheim Investigational Site 88
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Varna, Bulgarien
- Boehringer Ingelheim Investigational Site 82
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Veliko Tarnovo, Bulgarien
- Boehringer Ingelheim Investigational Site 83
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Copenhagen, Danmark
- Boehringer Ingelheim Investigational Site 69
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Ambleuteuse, Frankrike
- Boehringer Ingelheim Investigational Site 25
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Ardres, Frankrike
- Boehringer Ingelheim Investigational Site 68
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Arnac pompadour, Frankrike
- Boehringer Ingelheim Investigational Site 26
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Audincourt, Frankrike
- Boehringer Ingelheim Investigational Site 27
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Bart, Frankrike
- Boehringer Ingelheim Investigational Site 28
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Besançon, Frankrike
- Boehringer Ingelheim Investigational Site 29
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Buissière galant, Frankrike
- Boehringer Ingelheim Investigational Site 30
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Chalus, Frankrike
- Boehringer Ingelheim Investigational Site 32
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Charbrignac, Frankrike
- Boehringer Ingelheim Investigational Site 31
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Coussac Bonneval, Frankrike
- Boehringer Ingelheim Investigational Site 33
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Decines, Frankrike
- Boehringer Ingelheim Investigational Site 34
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Eckwersheim, Frankrike
- Boehringer Ingelheim Investigational Site 35
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Geneuille, Frankrike
- Boehringer Ingelheim Investigational Site 36
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Glandon, Frankrike
- Boehringer Ingelheim Investigational Site 37
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Gruson, Frankrike
- Boehringer Ingelheim Investigational Site 65
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Halluin, Frankrike
- Boehringer Ingelheim Investigational Site 38
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Lanouaille, Frankrike
- Boehringer Ingelheim Investigational Site 39
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Le Haillan, Frankrike
- Boehringer Ingelheim Investigational Site 40
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Le catelet, Frankrike
- Boehringer Ingelheim Investigational Site 67
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Lille, Frankrike
- Boehringer Ingelheim Investigational Site 41
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Limoges, Frankrike
- Boehringer Ingelheim Investigational Site 42
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Lomme, Frankrike
- Boehringer Ingelheim Investigational Site 43
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Lyon, Frankrike
- Boehringer Ingelheim Investigational Site 44
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Marseille, Frankrike
- Boehringer Ingelheim Investigational Site 45
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Merignac, Frankrike
- Boehringer Ingelheim Investigational Site 46
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Nexon, Frankrike
- Boehringer Ingelheim Investigational Site 47
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Noaillan, Frankrike
- Boehringer Ingelheim Investigational Site 48
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Paris, Frankrike
- Boehringer Ingelheim Investigational Site 24
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Pompadour, Frankrike
- Boehringer Ingelheim Investigational Site 49
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Saint Martial d'Albarede, Frankrike
- Boehringer Ingelheim Investigational Site 50
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Saint Martin Sepert, Frankrike
- Boehringer Ingelheim Investigational Site 51
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Saint Saud Lacousserie, Frankrike
- Boehringer Ingelheim Investigational Site 52
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Saint Sornin Lavolps, Frankrike
- Boehringer Ingelheim Investigational Site 53
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Saint Yrieix la Perche, Frankrike
- Boehringer Ingelheim Investigational Site 54
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Saint-Hilaire-les-Places, Frankrike
- Boehringer Ingelheim Investigational Site 55
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Schiltigheim, Frankrike
- Boehringer Ingelheim Investigational Site 56
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Sochaux, Frankrike
- Boehringer Ingelheim Investigational Site 57
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Strasbourg, Frankrike
- Boehringer Ingelheim Investigational Site 58
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Talence, Frankrike
- Boehringer Ingelheim Investigational Site 59
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Thiviers, Frankrike
- Boehringer Ingelheim Investigational Site 60
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Tourcoing, Frankrike
- Boehringer Ingelheim Investigational Site 66
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Tourmignies, Frankrike
- Boehringer Ingelheim Investigational Site 61
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Villenave d'Ornon, Frankrike
- Boehringer Ingelheim Investigational Site 62
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Voujeaucourt, Frankrike
- Boehringer Ingelheim Investigational Site 63
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Weyersheim, Frankrike
- Boehringer Ingelheim Investigational Site 64
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Banska Bystrica, Slovakien
- Boehringer Ingelheim Investigational Site 122
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Bardejov, Slovakien
- Boehringer Ingelheim Investigational Site 127
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Bratislava, Slovakien
- Boehringer Ingelheim Investigational Site 152
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Cierna nad Tisou, Slovakien
- Boehringer Ingelheim Investigational Site 146
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Cierne Klacany, Slovakien
- Boehringer Ingelheim Investigational Site 149
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Cierny Brod, Slovakien
- Boehringer Ingelheim Investigational Site 154
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Dolne Kockovce, Slovakien
- Boehringer Ingelheim Investigational Site 139
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Horny Vadicov, Slovakien
- Boehringer Ingelheim Investigational Site 141
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Ivanka pri Dunaji, Slovakien
- Boehringer Ingelheim Investigational Site 137
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Jelka, Slovakien
- Boehringer Ingelheim Investigational Site 140
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Kokava nad Rimavicou, Slovakien
- Boehringer Ingelheim Investigational Site 159
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Kosice, Slovakien
- Boehringer Ingelheim Investigational Site 125
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Kostany nad Turcom, Slovakien
- Boehringer Ingelheim Investigational Site 158
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Krasno nad Kysucou, Slovakien
- Boehringer Ingelheim Investigational Site 160
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Lalinok, Slovakien
- Boehringer Ingelheim Investigational Site 134
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Lastovce, Slovakien
- Boehringer Ingelheim Investigational Site 120
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Liptovsky Hradok, Slovakien
- Boehringer Ingelheim Investigational Site 155
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Lucenec, Slovakien
- Boehringer Ingelheim Investigational Site 145
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Nitra, Slovakien
- Boehringer Ingelheim Investigational Site 144
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Nove Mesto nad Vahom, Slovakien
- Boehringer Ingelheim Investigational Site 119
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Nove Zamky, Slovakien
- Boehringer Ingelheim Investigational Site 150
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Odorin, Slovakien
- Boehringer Ingelheim Investigational Site 124
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Oscadnica, Slovakien
- Boehringer Ingelheim Investigational Site 142
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Poprad, Slovakien
- Boehringer Ingelheim Investigational Site 157
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Povazska Bystrica, Slovakien
- Boehringer Ingelheim Investigational Site 128
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Povazsky Chlmec, Slovakien
- Boehringer Ingelheim Investigational Site 132
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Presov, Slovakien
- Boehringer Ingelheim Investigational Site 118
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Puchov, Slovakien
- Boehringer Ingelheim Investigational Site 138
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Radola, Slovakien
- Boehringer Ingelheim Investigational Site 143
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Resov, Slovakien
- Boehringer Ingelheim Investigational Site 153
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Revuca, Slovakien
- Boehringer Ingelheim Investigational Site 156
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Rozkovany, Slovakien
- Boehringer Ingelheim Investigational Site 147
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Rudinka, Slovakien
- Boehringer Ingelheim Investigational Site 131
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Sabinov, Slovakien
- Boehringer Ingelheim Investigational Site 126
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Skalite, Slovakien
- Boehringer Ingelheim Investigational Site 161
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Spisska Nova Ves, Slovakien
- Boehringer Ingelheim Investigational Site 123
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Stranavy, Slovakien
- Boehringer Ingelheim Investigational Site 130
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Trebisov, Slovakien
- Boehringer Ingelheim Investigational Site 121
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Trnava, Slovakien
- Boehringer Ingelheim Investigational Site 151
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Trnove, Slovakien
- Boehringer Ingelheim Investigational Site 129
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Valasska Bela, Slovakien
- Boehringer Ingelheim Investigational Site 135
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Vrable, Slovakien
- Boehringer Ingelheim Investigational Site 148
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Zilina, Slovakien
- Boehringer Ingelheim Investigational Site 133
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Zvolen, Slovakien
- Boehringer Ingelheim Investigational Site 136
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Baleares, Spanien
- Boehringer Ingelheim Investigational Site 23
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Barcelona, Spanien
- Boehringer Ingelheim Investigational Site 22
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Ciudad Real, Spanien
- Boehringer Ingelheim Investigational Site 15
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Galicia, Spanien
- Boehringer Ingelheim Investigational Site 16
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Madrid, Spanien
- Boehringer Ingelheim Investigational Site 17
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Murcia, Spanien
- Boehringer Ingelheim Investigational Site 18
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Sevilla, Spanien
- Boehringer Ingelheim Investigational Site 19
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Valencia, Spanien
- Boehringer Ingelheim Investigational Site 20
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Zaragoza, Spanien
- Boehringer Ingelheim Investigational Site 21
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Brighton, Storbritannien
- Boehringer Ingelheim Investigational Site 71
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Cheadle, Storbritannien
- Boehringer Ingelheim Investigational Site 76
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Essex, Storbritannien
- Boehringer Ingelheim Investigational Site 78
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London, Storbritannien
- Boehringer Ingelheim Investigational Site 70
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Manchester, Storbritannien
- Boehringer Ingelheim Investigational Site 77
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Middlesex, Storbritannien
- Boehringer Ingelheim Investigational Site 74
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Romford, Storbritannien
- Boehringer Ingelheim Investigational Site 73
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Stockport, Storbritannien
- Boehringer Ingelheim Investigational Site 75
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Surrey, Storbritannien
- Boehringer Ingelheim Investigational Site 72
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?eská Lípa, Tjeckien
- Boehringer Ingelheim Investigational Site 92
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?eské Bud?jovice, Tjeckien
- Boehringer Ingelheim Investigational Site 93
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?eský Krumlov, Tjeckien
- Boehringer Ingelheim Investigational Site 94
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B?eclav, Tjeckien
- Boehringer Ingelheim Investigational Site 90
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Benesov u Prahy, Tjeckien
- Boehringer Ingelheim Investigational Site 89
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Brno, Tjeckien
- Boehringer Ingelheim Investigational Site 91
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Chomutov, Tjeckien
- Boehringer Ingelheim Investigational Site 95
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Domazlice, Tjeckien
- Boehringer Ingelheim Investigational Site 96
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Havlí?k?v Brod, Tjeckien
- Boehringer Ingelheim Investigational Site 98
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Haví?ov, Tjeckien
- Boehringer Ingelheim Investigational Site 97
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Ho?ovice, Tjeckien
- Boehringer Ingelheim Investigational Site 99
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Hradec Králové, Tjeckien
- Boehringer Ingelheim Investigational Site 100
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Ivan?ice, Tjeckien
- Boehringer Ingelheim Investigational Site 101
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Krom??íz, Tjeckien
- Boehringer Ingelheim Investigational Site 102
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Kyjov, Tjeckien
- Boehringer Ingelheim Investigational Site 103
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Liberec, Tjeckien
- Boehringer Ingelheim Investigational Site 104
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Louny, Tjeckien
- Boehringer Ingelheim Investigational Site 105
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Most, Tjeckien
- Boehringer Ingelheim Investigational Site 106
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Nový Bor, Tjeckien
- Boehringer Ingelheim Investigational Site 107
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Odry, Tjeckien
- Boehringer Ingelheim Investigational Site 108
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Olomouc, Tjeckien
- Boehringer Ingelheim Investigational Site 109
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Pardubice, Tjeckien
- Boehringer Ingelheim Investigational Site 110
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Plze?, Tjeckien
- Boehringer Ingelheim Investigational Site 111
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Praha, Tjeckien
- Boehringer Ingelheim Investigational Site 112
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Sternberk, Tjeckien
- Boehringer Ingelheim Investigational Site 113
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Tehovec, Tjeckien
- Boehringer Ingelheim Investigational Site 115
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Teplice, Tjeckien
- Boehringer Ingelheim Investigational Site 116
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Tábor, Tjeckien
- Boehringer Ingelheim Investigational Site 114
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Valasské Mezi?í?í, Tjeckien
- Boehringer Ingelheim Investigational Site 117
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Berlin, Tyskland
- Boehringer Ingelheim Investigational Site 9
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Bremen, Tyskland
- Boehringer Ingelheim Investigational Site 3
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Chemnitz, Tyskland
- Boehringer Ingelheim Investigational Site 10
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Düsseldorf, Tyskland
- Boehringer Ingelheim Investigational Site 5
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Essen, Tyskland
- Boehringer Ingelheim Investigational Site 6
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Frankfurt, Tyskland
- Boehringer Ingelheim Investigational Site 1
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Hannover, Tyskland
- Boehringer Ingelheim Investigational Site 8
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Heidelberg, Tyskland
- Boehringer Ingelheim Investigational Site 14
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Leipzig, Tyskland
- Boehringer Ingelheim Investigational Site 11
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Mannheim, Tyskland
- Boehringer Ingelheim Investigational Site 2
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Marburg, Tyskland
- Boehringer Ingelheim Investigational Site 7
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München, Tyskland
- Boehringer Ingelheim Investigational Site 13
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Nürnberg, Tyskland
- Boehringer Ingelheim Investigational Site 4
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Rostock, Tyskland
- Boehringer Ingelheim Investigational Site 12
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion criteria:
- Pradaxa® prescribers (cardiologists and primary care physicians)
- Patients with atrial fibrillation treated with Pradaxa®
Exclusion criteria:
As defined in Summary of Product Characteristics for patients treated with Pradaxa®
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Patienter
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Läkare
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)
Tidsram: Day 1
|
The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group. |
Day 1
|
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)
Tidsram: Day 1
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The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding.
This Outcome measure is applicable only for the Patients group.
|
Day 1
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1160.149
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