- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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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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Brighton, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 71
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Cheadle, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 76
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Essex, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 78
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London, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 70
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Manchester, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 77
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Middlesex, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 74
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Romford, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 73
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Stockport, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 75
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Surrey, Det Forenede Kongerige
- Boehringer Ingelheim Investigational Site 72
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Ambleuteuse, Frankrig
- Boehringer Ingelheim Investigational Site 25
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Ardres, Frankrig
- Boehringer Ingelheim Investigational Site 68
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Arnac pompadour, Frankrig
- Boehringer Ingelheim Investigational Site 26
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Audincourt, Frankrig
- Boehringer Ingelheim Investigational Site 27
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Bart, Frankrig
- Boehringer Ingelheim Investigational Site 28
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Besançon, Frankrig
- Boehringer Ingelheim Investigational Site 29
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Buissière galant, Frankrig
- Boehringer Ingelheim Investigational Site 30
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Chalus, Frankrig
- Boehringer Ingelheim Investigational Site 32
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Charbrignac, Frankrig
- Boehringer Ingelheim Investigational Site 31
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Coussac Bonneval, Frankrig
- Boehringer Ingelheim Investigational Site 33
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Decines, Frankrig
- Boehringer Ingelheim Investigational Site 34
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Eckwersheim, Frankrig
- Boehringer Ingelheim Investigational Site 35
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Geneuille, Frankrig
- Boehringer Ingelheim Investigational Site 36
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Glandon, Frankrig
- Boehringer Ingelheim Investigational Site 37
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Gruson, Frankrig
- Boehringer Ingelheim Investigational Site 65
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Halluin, Frankrig
- Boehringer Ingelheim Investigational Site 38
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Lanouaille, Frankrig
- Boehringer Ingelheim Investigational Site 39
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Le Haillan, Frankrig
- Boehringer Ingelheim Investigational Site 40
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Le catelet, Frankrig
- Boehringer Ingelheim Investigational Site 67
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Lille, Frankrig
- Boehringer Ingelheim Investigational Site 41
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Limoges, Frankrig
- Boehringer Ingelheim Investigational Site 42
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Lomme, Frankrig
- Boehringer Ingelheim Investigational Site 43
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Lyon, Frankrig
- Boehringer Ingelheim Investigational Site 44
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Marseille, Frankrig
- Boehringer Ingelheim Investigational Site 45
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Merignac, Frankrig
- Boehringer Ingelheim Investigational Site 46
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Nexon, Frankrig
- Boehringer Ingelheim Investigational Site 47
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Noaillan, Frankrig
- Boehringer Ingelheim Investigational Site 48
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Paris, Frankrig
- Boehringer Ingelheim Investigational Site 24
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Pompadour, Frankrig
- Boehringer Ingelheim Investigational Site 49
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Saint Martial d'Albarede, Frankrig
- Boehringer Ingelheim Investigational Site 50
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Saint Martin Sepert, Frankrig
- Boehringer Ingelheim Investigational Site 51
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Saint Saud Lacousserie, Frankrig
- Boehringer Ingelheim Investigational Site 52
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Saint Sornin Lavolps, Frankrig
- Boehringer Ingelheim Investigational Site 53
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Saint Yrieix la Perche, Frankrig
- Boehringer Ingelheim Investigational Site 54
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Saint-Hilaire-les-Places, Frankrig
- Boehringer Ingelheim Investigational Site 55
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Schiltigheim, Frankrig
- Boehringer Ingelheim Investigational Site 56
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Sochaux, Frankrig
- Boehringer Ingelheim Investigational Site 57
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Strasbourg, Frankrig
- Boehringer Ingelheim Investigational Site 58
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Talence, Frankrig
- Boehringer Ingelheim Investigational Site 59
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Thiviers, Frankrig
- Boehringer Ingelheim Investigational Site 60
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Tourcoing, Frankrig
- Boehringer Ingelheim Investigational Site 66
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Tourmignies, Frankrig
- Boehringer Ingelheim Investigational Site 61
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Villenave d'Ornon, Frankrig
- Boehringer Ingelheim Investigational Site 62
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Voujeaucourt, Frankrig
- Boehringer Ingelheim Investigational Site 63
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Weyersheim, Frankrig
- Boehringer Ingelheim Investigational Site 64
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Banska Bystrica, Slovakiet
- Boehringer Ingelheim Investigational Site 122
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Bardejov, Slovakiet
- Boehringer Ingelheim Investigational Site 127
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Bratislava, Slovakiet
- Boehringer Ingelheim Investigational Site 152
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Cierna nad Tisou, Slovakiet
- Boehringer Ingelheim Investigational Site 146
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Cierne Klacany, Slovakiet
- Boehringer Ingelheim Investigational Site 149
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Cierny Brod, Slovakiet
- Boehringer Ingelheim Investigational Site 154
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Dolne Kockovce, Slovakiet
- Boehringer Ingelheim Investigational Site 139
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Horny Vadicov, Slovakiet
- Boehringer Ingelheim Investigational Site 141
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Ivanka pri Dunaji, Slovakiet
- Boehringer Ingelheim Investigational Site 137
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Jelka, Slovakiet
- Boehringer Ingelheim Investigational Site 140
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Kokava nad Rimavicou, Slovakiet
- Boehringer Ingelheim Investigational Site 159
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Kosice, Slovakiet
- Boehringer Ingelheim Investigational Site 125
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Kostany nad Turcom, Slovakiet
- Boehringer Ingelheim Investigational Site 158
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Krasno nad Kysucou, Slovakiet
- Boehringer Ingelheim Investigational Site 160
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Lalinok, Slovakiet
- Boehringer Ingelheim Investigational Site 134
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Lastovce, Slovakiet
- Boehringer Ingelheim Investigational Site 120
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Liptovsky Hradok, Slovakiet
- Boehringer Ingelheim Investigational Site 155
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Lucenec, Slovakiet
- Boehringer Ingelheim Investigational Site 145
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Nitra, Slovakiet
- Boehringer Ingelheim Investigational Site 144
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Nove Mesto nad Vahom, Slovakiet
- Boehringer Ingelheim Investigational Site 119
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Nove Zamky, Slovakiet
- Boehringer Ingelheim Investigational Site 150
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Odorin, Slovakiet
- Boehringer Ingelheim Investigational Site 124
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Oscadnica, Slovakiet
- Boehringer Ingelheim Investigational Site 142
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Poprad, Slovakiet
- Boehringer Ingelheim Investigational Site 157
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Povazska Bystrica, Slovakiet
- Boehringer Ingelheim Investigational Site 128
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Povazsky Chlmec, Slovakiet
- Boehringer Ingelheim Investigational Site 132
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Presov, Slovakiet
- Boehringer Ingelheim Investigational Site 118
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Puchov, Slovakiet
- Boehringer Ingelheim Investigational Site 138
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Radola, Slovakiet
- Boehringer Ingelheim Investigational Site 143
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Resov, Slovakiet
- Boehringer Ingelheim Investigational Site 153
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Revuca, Slovakiet
- Boehringer Ingelheim Investigational Site 156
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Rozkovany, Slovakiet
- Boehringer Ingelheim Investigational Site 147
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Rudinka, Slovakiet
- Boehringer Ingelheim Investigational Site 131
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Sabinov, Slovakiet
- Boehringer Ingelheim Investigational Site 126
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Skalite, Slovakiet
- Boehringer Ingelheim Investigational Site 161
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Spisska Nova Ves, Slovakiet
- Boehringer Ingelheim Investigational Site 123
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Stranavy, Slovakiet
- Boehringer Ingelheim Investigational Site 130
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Trebisov, Slovakiet
- Boehringer Ingelheim Investigational Site 121
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Trnava, Slovakiet
- Boehringer Ingelheim Investigational Site 151
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Trnove, Slovakiet
- Boehringer Ingelheim Investigational Site 129
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Valasska Bela, Slovakiet
- Boehringer Ingelheim Investigational Site 135
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Vrable, Slovakiet
- Boehringer Ingelheim Investigational Site 148
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Zilina, Slovakiet
- Boehringer Ingelheim Investigational Site 133
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Zvolen, Slovakiet
- 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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?eská Lípa, Tjekkiet
- Boehringer Ingelheim Investigational Site 92
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?eské Bud?jovice, Tjekkiet
- Boehringer Ingelheim Investigational Site 93
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?eský Krumlov, Tjekkiet
- Boehringer Ingelheim Investigational Site 94
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B?eclav, Tjekkiet
- Boehringer Ingelheim Investigational Site 90
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Benesov u Prahy, Tjekkiet
- Boehringer Ingelheim Investigational Site 89
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Brno, Tjekkiet
- Boehringer Ingelheim Investigational Site 91
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Chomutov, Tjekkiet
- Boehringer Ingelheim Investigational Site 95
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Domazlice, Tjekkiet
- Boehringer Ingelheim Investigational Site 96
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Havlí?k?v Brod, Tjekkiet
- Boehringer Ingelheim Investigational Site 98
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Haví?ov, Tjekkiet
- Boehringer Ingelheim Investigational Site 97
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Ho?ovice, Tjekkiet
- Boehringer Ingelheim Investigational Site 99
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Hradec Králové, Tjekkiet
- Boehringer Ingelheim Investigational Site 100
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Ivan?ice, Tjekkiet
- Boehringer Ingelheim Investigational Site 101
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Krom??íz, Tjekkiet
- Boehringer Ingelheim Investigational Site 102
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Kyjov, Tjekkiet
- Boehringer Ingelheim Investigational Site 103
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Liberec, Tjekkiet
- Boehringer Ingelheim Investigational Site 104
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Louny, Tjekkiet
- Boehringer Ingelheim Investigational Site 105
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Most, Tjekkiet
- Boehringer Ingelheim Investigational Site 106
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Nový Bor, Tjekkiet
- Boehringer Ingelheim Investigational Site 107
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Odry, Tjekkiet
- Boehringer Ingelheim Investigational Site 108
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Olomouc, Tjekkiet
- Boehringer Ingelheim Investigational Site 109
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Pardubice, Tjekkiet
- Boehringer Ingelheim Investigational Site 110
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Plze?, Tjekkiet
- Boehringer Ingelheim Investigational Site 111
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Praha, Tjekkiet
- Boehringer Ingelheim Investigational Site 112
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Sternberk, Tjekkiet
- Boehringer Ingelheim Investigational Site 113
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Tehovec, Tjekkiet
- Boehringer Ingelheim Investigational Site 115
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Teplice, Tjekkiet
- Boehringer Ingelheim Investigational Site 116
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Tábor, Tjekkiet
- Boehringer Ingelheim Investigational Site 114
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Valasské Mezi?í?í, Tjekkiet
- 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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patienter
|
Læger
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)
Tidsramme: 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
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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)
Tidsramme: Day 1
|
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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1160.149
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Henry Ford Health SystemTrukket tilbage
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz
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Occlutech International ABAfsluttetSecundum atrial septal defekter