- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01108796
Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan
This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions.
The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control.
In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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?adca, Slowenien
- Boehringer Ingelheim Investigational Site 34
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 2
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 3
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 4
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 5
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 6
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 7
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Banská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 8
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Bardejov, Slowenien
- Boehringer Ingelheim Investigational Site 10
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Bardejov, Slowenien
- Boehringer Ingelheim Investigational Site 11
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Bardejov, Slowenien
- Boehringer Ingelheim Investigational Site 12
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Bardejov, Slowenien
- Boehringer Ingelheim Investigational Site 9
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 13
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 14
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 15
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 16
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 17
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 18
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 19
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 20
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 21
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 22
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 23
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 24
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 25
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 26
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 27
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Bratislava, Slowenien
- Boehringer Ingelheim Investigational Site 28
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Brezno, Slowenien
- Boehringer Ingelheim Investigational Site 29
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Brezno, Slowenien
- Boehringer Ingelheim Investigational Site 30
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Brezno, Slowenien
- Boehringer Ingelheim Investigational Site 31
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Brezno, Slowenien
- Boehringer Ingelheim Investigational Site 32
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Byt?a, Slowenien
- Boehringer Ingelheim Investigational Site 33
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Bánovce nad Bebravou, Slowenien
- Boehringer Ingelheim Investigational Site 1
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Dolný Kubín, Slowenien
- Boehringer Ingelheim Investigational Site 35
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Dubnica nad Váhom, Slowenien
- Boehringer Ingelheim Investigational Site 36
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Dubnica nad Váhom, Slowenien
- Boehringer Ingelheim Investigational Site 37
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Dunajská Streda, Slowenien
- Boehringer Ingelheim Investigational Site 38
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Dunajská Streda, Slowenien
- Boehringer Ingelheim Investigational Site 39
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Dunajská Streda, Slowenien
- Boehringer Ingelheim Investigational Site 40
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Dunajská Streda, Slowenien
- Boehringer Ingelheim Investigational Site 41
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Dunajská Streda, Slowenien
- Boehringer Ingelheim Investigational Site 42
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Dunajská Streda, Slowenien
- Boehringer Ingelheim Investigational Site 43
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Galanta, Slowenien
- Boehringer Ingelheim Investigational Site 44
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Galanta, Slowenien
- Boehringer Ingelheim Investigational Site 45
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Handlová, Slowenien
- Boehringer Ingelheim Investigational Site 46
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Hlohovec, Slowenien
- Boehringer Ingelheim Investigational Site 47
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Hlohovec, Slowenien
- Boehringer Ingelheim Investigational Site 48
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Hnús?a, Slowenien
- Boehringer Ingelheim Investigational Site 49
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Hurbanovo, Slowenien
- Boehringer Ingelheim Investigational Site 50
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Jesenské, Slowenien
- Boehringer Ingelheim Investigational Site 51
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Kezmarok, Slowenien
- Boehringer Ingelheim Investigational Site 52
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Kolárovo, Slowenien
- Boehringer Ingelheim Investigational Site 53
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Komárno, Slowenien
- Boehringer Ingelheim Investigational Site 54
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Komárno, Slowenien
- Boehringer Ingelheim Investigational Site 55
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 56
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 57
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 58
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 59
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 60
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 61
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 62
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 63
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 64
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 65
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 66
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 67
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 68
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 69
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Kosice, Slowenien
- Boehringer Ingelheim Investigational Site 70
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Krá?ovský Chlmec, Slowenien
- Boehringer Ingelheim Investigational Site 71
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Kysucké Nové Mesto, Slowenien
- Boehringer Ingelheim Investigational Site 72
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Kysucké Nové Mesto, Slowenien
- Boehringer Ingelheim Investigational Site 73
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Kysucké Nové Mesto, Slowenien
- Boehringer Ingelheim Investigational Site 74
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Levice, Slowenien
- Boehringer Ingelheim Investigational Site 75
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Levice, Slowenien
- Boehringer Ingelheim Investigational Site 76
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Levice, Slowenien
- Boehringer Ingelheim Investigational Site 77
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Lipany, Slowenien
- Boehringer Ingelheim Investigational Site 78
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Lu?enec, Slowenien
- Boehringer Ingelheim Investigational Site 79
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Lu?enec, Slowenien
- Boehringer Ingelheim Investigational Site 80
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Lu?enec, Slowenien
- Boehringer Ingelheim Investigational Site 81
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Lu?enec, Slowenien
- Boehringer Ingelheim Investigational Site 82
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Martin, Slowenien
- Boehringer Ingelheim Investigational Site 83
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Martin, Slowenien
- Boehringer Ingelheim Investigational Site 84
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Martin, Slowenien
- Boehringer Ingelheim Investigational Site 85
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Michalovce, Slowenien
- Boehringer Ingelheim Investigational Site 86
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Michalovce, Slowenien
- Boehringer Ingelheim Investigational Site 87
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Michalovce, Slowenien
- Boehringer Ingelheim Investigational Site 88
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Myjava, Slowenien
- Boehringer Ingelheim Investigational Site 89
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Nitra, Slowenien
- Boehringer Ingelheim Investigational Site 91
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Nitra, Slowenien
- Boehringer Ingelheim Investigational Site 92
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Nitra, Slowenien
- Boehringer Ingelheim Investigational Site 93
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Nitra, Slowenien
- Boehringer Ingelheim Investigational Site 94
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Nové Mesto nad Váhom, Slowenien
- Boehringer Ingelheim Investigational Site 95
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Nové Mesto nad Váhom, Slowenien
- Boehringer Ingelheim Investigational Site 96
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Nové Mesto nad Váhom, Slowenien
- Boehringer Ingelheim Investigational Site 97
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Nové Zámky, Slowenien
- Boehringer Ingelheim Investigational Site 100
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Nové Zámky, Slowenien
- Boehringer Ingelheim Investigational Site 101
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Nové Zámky, Slowenien
- Boehringer Ingelheim Investigational Site 98
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Nové Zámky, Slowenien
- Boehringer Ingelheim Investigational Site 99
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Námestovo, Slowenien
- Boehringer Ingelheim Investigational Site 90
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Partizánske, Slowenien
- Boehringer Ingelheim Investigational Site 102
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Partizánske, Slowenien
- Boehringer Ingelheim Investigational Site 103
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Pezinok, Slowenien
- Boehringer Ingelheim Investigational Site 104
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Pies?any, Slowenien
- Boehringer Ingelheim Investigational Site 105
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Poprad, Slowenien
- Boehringer Ingelheim Investigational Site 106
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Poprad, Slowenien
- Boehringer Ingelheim Investigational Site 107
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Poprad, Slowenien
- Boehringer Ingelheim Investigational Site 108
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Povazská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 109
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Povazská Bystrica, Slowenien
- Boehringer Ingelheim Investigational Site 110
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Presov, Slowenien
- Boehringer Ingelheim Investigational Site 111
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Presov, Slowenien
- Boehringer Ingelheim Investigational Site 112
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Presov, Slowenien
- Boehringer Ingelheim Investigational Site 113
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Presov, Slowenien
- Boehringer Ingelheim Investigational Site 114
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Prievidza, Slowenien
- Boehringer Ingelheim Investigational Site 115
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Prievidza, Slowenien
- Boehringer Ingelheim Investigational Site 116
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Prievidza, Slowenien
- Boehringer Ingelheim Investigational Site 117
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Rajec, Slowenien
- Boehringer Ingelheim Investigational Site 118
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Revúca, Slowenien
- Boehringer Ingelheim Investigational Site 119
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Revúca, Slowenien
- Boehringer Ingelheim Investigational Site 120
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Rimavská Sobota, Slowenien
- Boehringer Ingelheim Investigational Site 121
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Rimavská Sobota, Slowenien
- Boehringer Ingelheim Investigational Site 122
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Rimavská Sobota, Slowenien
- Boehringer Ingelheim Investigational Site 123
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Roz?ava, Slowenien
- Boehringer Ingelheim Investigational Site 124
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Roz?ava, Slowenien
- Boehringer Ingelheim Investigational Site 125
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Ruzomberok, Slowenien
- Boehringer Ingelheim Investigational Site 126
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Ruzomberok, Slowenien
- Boehringer Ingelheim Investigational Site 127
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Sa?a, Slowenien
- Boehringer Ingelheim Investigational Site 128
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Sa?a, Slowenien
- Boehringer Ingelheim Investigational Site 129
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Sa?a, Slowenien
- Boehringer Ingelheim Investigational Site 130
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Se?ovce, Slowenien
- Boehringer Ingelheim Investigational Site 131
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Se?ovce, Slowenien
- Boehringer Ingelheim Investigational Site 132
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Skalica, Slowenien
- Boehringer Ingelheim Investigational Site 133
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Snina, Slowenien
- Boehringer Ingelheim Investigational Site 134
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Snina, Slowenien
- Boehringer Ingelheim Investigational Site 135
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Spisská Nová Ves, Slowenien
- Boehringer Ingelheim Investigational Site 136
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Spisská Nová Ves, Slowenien
- Boehringer Ingelheim Investigational Site 137
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Stará ?ubov?a, Slowenien
- Boehringer Ingelheim Investigational Site 138
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Stará ?ubov?a, Slowenien
- Boehringer Ingelheim Investigational Site 139
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Stará ?ubov?a, Slowenien
- Boehringer Ingelheim Investigational Site 140
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Stropkov, Slowenien
- Boehringer Ingelheim Investigational Site 141
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Stúrovo, Slowenien
- Boehringer Ingelheim Investigational Site 142
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Surany, Slowenien
- Boehringer Ingelheim Investigational Site 143
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Surany, Slowenien
- Boehringer Ingelheim Investigational Site 144
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Svit, Slowenien
- Boehringer Ingelheim Investigational Site 145
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Topo??any, Slowenien
- Boehringer Ingelheim Investigational Site 146
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Torna?a, Slowenien
- Boehringer Ingelheim Investigational Site 147
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Trebisov, Slowenien
- Boehringer Ingelheim Investigational Site 148
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Trebisov, Slowenien
- Boehringer Ingelheim Investigational Site 149
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Trebisov, Slowenien
- Boehringer Ingelheim Investigational Site 150
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Tren?ín, Slowenien
- Boehringer Ingelheim Investigational Site 151
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Tren?ín, Slowenien
- Boehringer Ingelheim Investigational Site 152
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Tren?ín, Slowenien
- Boehringer Ingelheim Investigational Site 153
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Tren?ín, Slowenien
- Boehringer Ingelheim Investigational Site 154
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Trnava, Slowenien
- Boehringer Ingelheim Investigational Site 155
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Trnava, Slowenien
- Boehringer Ingelheim Investigational Site 156
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Trnava, Slowenien
- Boehringer Ingelheim Investigational Site 157
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Trnava, Slowenien
- Boehringer Ingelheim Investigational Site 158
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Trstená, Slowenien
- Boehringer Ingelheim Investigational Site 159
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Tur?ianske Teplice, Slowenien
- Boehringer Ingelheim Investigational Site 160
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Turzovka, Slowenien
- Boehringer Ingelheim Investigational Site 161
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Ve?ké Kapusany, Slowenien
- Boehringer Ingelheim Investigational Site 162
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Ve?ké Kapusany, Slowenien
- Boehringer Ingelheim Investigational Site 163
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Ve?ký Krtís, Slowenien
- Boehringer Ingelheim Investigational Site 164
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Ve?ký Krtís, Slowenien
- Boehringer Ingelheim Investigational Site 165
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Vranov nad Top?ou, Slowenien
- Boehringer Ingelheim Investigational Site 167
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Vráble, Slowenien
- Boehringer Ingelheim Investigational Site 166
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Zarnovica, Slowenien
- Boehringer Ingelheim Investigational Site 168
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Zeliezovce, Slowenien
- Boehringer Ingelheim Investigational Site 169
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Zilina, Slowenien
- Boehringer Ingelheim Investigational Site 170
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Zilina, Slowenien
- Boehringer Ingelheim Investigational Site 171
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Zilina, Slowenien
- Boehringer Ingelheim Investigational Site 172
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Zilina, Slowenien
- Boehringer Ingelheim Investigational Site 173
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Zilina, Slowenien
- Boehringer Ingelheim Investigational Site 174
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Zilina, Slowenien
- Boehringer Ingelheim Investigational Site 175
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Zlaté Moravce, Slowenien
- Boehringer Ingelheim Investigational Site 176
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Zlaté Moravce, Slowenien
- Boehringer Ingelheim Investigational Site 177
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Zlaté Moravce, Slowenien
- Boehringer Ingelheim Investigational Site 178
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Zvolen, Slowenien
- Boehringer Ingelheim Investigational Site 179
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Zvolen, Slowenien
- Boehringer Ingelheim Investigational Site 180
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Zvolen, Slowenien
- Boehringer Ingelheim Investigational Site 181
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Zvolen, Slowenien
- Boehringer Ingelheim Investigational Site 182
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion criteria:
- Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients)
- Patients with hypertension under treatment with one or more antihypertensive drug
Exclusion criteria:
Patients are excluded according to the summary of product characteristics (SmPC).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Patients at cardiovascular risk
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
|
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Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Laboratory Parameters: Triglycerides
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Laboratory Parameters: Blood Glucose
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Assessment of Metabolic Effect
Zeitfenster: 24 weeks (Visit 1 to Visit 3)
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Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
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24 weeks (Visit 1 to Visit 3)
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 502.579
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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