- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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?adca, Slovenia
- Boehringer Ingelheim Investigational Site 34
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Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 2
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Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 3
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Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 4
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Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 5
-
Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 6
-
Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 7
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Banská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 8
-
Bardejov, Slovenia
- Boehringer Ingelheim Investigational Site 10
-
Bardejov, Slovenia
- Boehringer Ingelheim Investigational Site 11
-
Bardejov, Slovenia
- Boehringer Ingelheim Investigational Site 12
-
Bardejov, Slovenia
- Boehringer Ingelheim Investigational Site 9
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 13
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 14
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 15
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 16
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 17
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 18
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 19
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 20
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 21
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 22
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 23
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 24
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 25
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 26
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 27
-
Bratislava, Slovenia
- Boehringer Ingelheim Investigational Site 28
-
Brezno, Slovenia
- Boehringer Ingelheim Investigational Site 29
-
Brezno, Slovenia
- Boehringer Ingelheim Investigational Site 30
-
Brezno, Slovenia
- Boehringer Ingelheim Investigational Site 31
-
Brezno, Slovenia
- Boehringer Ingelheim Investigational Site 32
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Byt?a, Slovenia
- Boehringer Ingelheim Investigational Site 33
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Bánovce nad Bebravou, Slovenia
- Boehringer Ingelheim Investigational Site 1
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Dolný Kubín, Slovenia
- Boehringer Ingelheim Investigational Site 35
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Dubnica nad Váhom, Slovenia
- Boehringer Ingelheim Investigational Site 36
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Dubnica nad Váhom, Slovenia
- Boehringer Ingelheim Investigational Site 37
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Dunajská Streda, Slovenia
- Boehringer Ingelheim Investigational Site 38
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Dunajská Streda, Slovenia
- Boehringer Ingelheim Investigational Site 39
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Dunajská Streda, Slovenia
- Boehringer Ingelheim Investigational Site 40
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Dunajská Streda, Slovenia
- Boehringer Ingelheim Investigational Site 41
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Dunajská Streda, Slovenia
- Boehringer Ingelheim Investigational Site 42
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Dunajská Streda, Slovenia
- Boehringer Ingelheim Investigational Site 43
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Galanta, Slovenia
- Boehringer Ingelheim Investigational Site 44
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Galanta, Slovenia
- Boehringer Ingelheim Investigational Site 45
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Handlová, Slovenia
- Boehringer Ingelheim Investigational Site 46
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Hlohovec, Slovenia
- Boehringer Ingelheim Investigational Site 47
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Hlohovec, Slovenia
- Boehringer Ingelheim Investigational Site 48
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Hnús?a, Slovenia
- Boehringer Ingelheim Investigational Site 49
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Hurbanovo, Slovenia
- Boehringer Ingelheim Investigational Site 50
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Jesenské, Slovenia
- Boehringer Ingelheim Investigational Site 51
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Kezmarok, Slovenia
- Boehringer Ingelheim Investigational Site 52
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Kolárovo, Slovenia
- Boehringer Ingelheim Investigational Site 53
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Komárno, Slovenia
- Boehringer Ingelheim Investigational Site 54
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Komárno, Slovenia
- Boehringer Ingelheim Investigational Site 55
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Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 56
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 57
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 58
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 59
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 60
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 61
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 62
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 63
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 64
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 65
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 66
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 67
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 68
-
Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 69
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Kosice, Slovenia
- Boehringer Ingelheim Investigational Site 70
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Krá?ovský Chlmec, Slovenia
- Boehringer Ingelheim Investigational Site 71
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Kysucké Nové Mesto, Slovenia
- Boehringer Ingelheim Investigational Site 72
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Kysucké Nové Mesto, Slovenia
- Boehringer Ingelheim Investigational Site 73
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Kysucké Nové Mesto, Slovenia
- Boehringer Ingelheim Investigational Site 74
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Levice, Slovenia
- Boehringer Ingelheim Investigational Site 75
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Levice, Slovenia
- Boehringer Ingelheim Investigational Site 76
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Levice, Slovenia
- Boehringer Ingelheim Investigational Site 77
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Lipany, Slovenia
- Boehringer Ingelheim Investigational Site 78
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Lu?enec, Slovenia
- Boehringer Ingelheim Investigational Site 79
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Lu?enec, Slovenia
- Boehringer Ingelheim Investigational Site 80
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Lu?enec, Slovenia
- Boehringer Ingelheim Investigational Site 81
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Lu?enec, Slovenia
- Boehringer Ingelheim Investigational Site 82
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Martin, Slovenia
- Boehringer Ingelheim Investigational Site 83
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Martin, Slovenia
- Boehringer Ingelheim Investigational Site 84
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Martin, Slovenia
- Boehringer Ingelheim Investigational Site 85
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Michalovce, Slovenia
- Boehringer Ingelheim Investigational Site 86
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Michalovce, Slovenia
- Boehringer Ingelheim Investigational Site 87
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Michalovce, Slovenia
- Boehringer Ingelheim Investigational Site 88
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Myjava, Slovenia
- Boehringer Ingelheim Investigational Site 89
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Nitra, Slovenia
- Boehringer Ingelheim Investigational Site 91
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Nitra, Slovenia
- Boehringer Ingelheim Investigational Site 92
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Nitra, Slovenia
- Boehringer Ingelheim Investigational Site 93
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Nitra, Slovenia
- Boehringer Ingelheim Investigational Site 94
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Nové Mesto nad Váhom, Slovenia
- Boehringer Ingelheim Investigational Site 95
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Nové Mesto nad Váhom, Slovenia
- Boehringer Ingelheim Investigational Site 96
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Nové Mesto nad Váhom, Slovenia
- Boehringer Ingelheim Investigational Site 97
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Nové Zámky, Slovenia
- Boehringer Ingelheim Investigational Site 100
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Nové Zámky, Slovenia
- Boehringer Ingelheim Investigational Site 101
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Nové Zámky, Slovenia
- Boehringer Ingelheim Investigational Site 98
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Nové Zámky, Slovenia
- Boehringer Ingelheim Investigational Site 99
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Námestovo, Slovenia
- Boehringer Ingelheim Investigational Site 90
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Partizánske, Slovenia
- Boehringer Ingelheim Investigational Site 102
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Partizánske, Slovenia
- Boehringer Ingelheim Investigational Site 103
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Pezinok, Slovenia
- Boehringer Ingelheim Investigational Site 104
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Pies?any, Slovenia
- Boehringer Ingelheim Investigational Site 105
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Poprad, Slovenia
- Boehringer Ingelheim Investigational Site 106
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Poprad, Slovenia
- Boehringer Ingelheim Investigational Site 107
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Poprad, Slovenia
- Boehringer Ingelheim Investigational Site 108
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Povazská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 109
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Povazská Bystrica, Slovenia
- Boehringer Ingelheim Investigational Site 110
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Presov, Slovenia
- Boehringer Ingelheim Investigational Site 111
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Presov, Slovenia
- Boehringer Ingelheim Investigational Site 112
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Presov, Slovenia
- Boehringer Ingelheim Investigational Site 113
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Presov, Slovenia
- Boehringer Ingelheim Investigational Site 114
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Prievidza, Slovenia
- Boehringer Ingelheim Investigational Site 115
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Prievidza, Slovenia
- Boehringer Ingelheim Investigational Site 116
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Prievidza, Slovenia
- Boehringer Ingelheim Investigational Site 117
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Rajec, Slovenia
- Boehringer Ingelheim Investigational Site 118
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Revúca, Slovenia
- Boehringer Ingelheim Investigational Site 119
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Revúca, Slovenia
- Boehringer Ingelheim Investigational Site 120
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Rimavská Sobota, Slovenia
- Boehringer Ingelheim Investigational Site 121
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Rimavská Sobota, Slovenia
- Boehringer Ingelheim Investigational Site 122
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Rimavská Sobota, Slovenia
- Boehringer Ingelheim Investigational Site 123
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Roz?ava, Slovenia
- Boehringer Ingelheim Investigational Site 124
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Roz?ava, Slovenia
- Boehringer Ingelheim Investigational Site 125
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Ruzomberok, Slovenia
- Boehringer Ingelheim Investigational Site 126
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Ruzomberok, Slovenia
- Boehringer Ingelheim Investigational Site 127
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Sa?a, Slovenia
- Boehringer Ingelheim Investigational Site 128
-
Sa?a, Slovenia
- Boehringer Ingelheim Investigational Site 129
-
Sa?a, Slovenia
- Boehringer Ingelheim Investigational Site 130
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Se?ovce, Slovenia
- Boehringer Ingelheim Investigational Site 131
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Se?ovce, Slovenia
- Boehringer Ingelheim Investigational Site 132
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Skalica, Slovenia
- Boehringer Ingelheim Investigational Site 133
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Snina, Slovenia
- Boehringer Ingelheim Investigational Site 134
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Snina, Slovenia
- Boehringer Ingelheim Investigational Site 135
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Spisská Nová Ves, Slovenia
- Boehringer Ingelheim Investigational Site 136
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Spisská Nová Ves, Slovenia
- Boehringer Ingelheim Investigational Site 137
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Stará ?ubov?a, Slovenia
- Boehringer Ingelheim Investigational Site 138
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Stará ?ubov?a, Slovenia
- Boehringer Ingelheim Investigational Site 139
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Stará ?ubov?a, Slovenia
- Boehringer Ingelheim Investigational Site 140
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Stropkov, Slovenia
- Boehringer Ingelheim Investigational Site 141
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Stúrovo, Slovenia
- Boehringer Ingelheim Investigational Site 142
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Surany, Slovenia
- Boehringer Ingelheim Investigational Site 143
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Surany, Slovenia
- Boehringer Ingelheim Investigational Site 144
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Svit, Slovenia
- Boehringer Ingelheim Investigational Site 145
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Topo??any, Slovenia
- Boehringer Ingelheim Investigational Site 146
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Torna?a, Slovenia
- Boehringer Ingelheim Investigational Site 147
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Trebisov, Slovenia
- Boehringer Ingelheim Investigational Site 148
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Trebisov, Slovenia
- Boehringer Ingelheim Investigational Site 149
-
Trebisov, Slovenia
- Boehringer Ingelheim Investigational Site 150
-
Tren?ín, Slovenia
- Boehringer Ingelheim Investigational Site 151
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Tren?ín, Slovenia
- Boehringer Ingelheim Investigational Site 152
-
Tren?ín, Slovenia
- Boehringer Ingelheim Investigational Site 153
-
Tren?ín, Slovenia
- Boehringer Ingelheim Investigational Site 154
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Trnava, Slovenia
- Boehringer Ingelheim Investigational Site 155
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Trnava, Slovenia
- Boehringer Ingelheim Investigational Site 156
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Trnava, Slovenia
- Boehringer Ingelheim Investigational Site 157
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Trnava, Slovenia
- Boehringer Ingelheim Investigational Site 158
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Trstená, Slovenia
- Boehringer Ingelheim Investigational Site 159
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Tur?ianske Teplice, Slovenia
- Boehringer Ingelheim Investigational Site 160
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Turzovka, Slovenia
- Boehringer Ingelheim Investigational Site 161
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Ve?ké Kapusany, Slovenia
- Boehringer Ingelheim Investigational Site 162
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Ve?ké Kapusany, Slovenia
- Boehringer Ingelheim Investigational Site 163
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Ve?ký Krtís, Slovenia
- Boehringer Ingelheim Investigational Site 164
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Ve?ký Krtís, Slovenia
- Boehringer Ingelheim Investigational Site 165
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Vranov nad Top?ou, Slovenia
- Boehringer Ingelheim Investigational Site 167
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Vráble, Slovenia
- Boehringer Ingelheim Investigational Site 166
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Zarnovica, Slovenia
- Boehringer Ingelheim Investigational Site 168
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Zeliezovce, Slovenia
- Boehringer Ingelheim Investigational Site 169
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Zilina, Slovenia
- Boehringer Ingelheim Investigational Site 170
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Zilina, Slovenia
- Boehringer Ingelheim Investigational Site 171
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Zilina, Slovenia
- Boehringer Ingelheim Investigational Site 172
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Zilina, Slovenia
- Boehringer Ingelheim Investigational Site 173
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Zilina, Slovenia
- Boehringer Ingelheim Investigational Site 174
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Zilina, Slovenia
- Boehringer Ingelheim Investigational Site 175
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Zlaté Moravce, Slovenia
- Boehringer Ingelheim Investigational Site 176
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Zlaté Moravce, Slovenia
- Boehringer Ingelheim Investigational Site 177
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Zlaté Moravce, Slovenia
- Boehringer Ingelheim Investigational Site 178
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Zvolen, Slovenia
- Boehringer Ingelheim Investigational Site 179
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Zvolen, Slovenia
- Boehringer Ingelheim Investigational Site 180
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Zvolen, Slovenia
- Boehringer Ingelheim Investigational Site 181
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Zvolen, Slovenia
- Boehringer Ingelheim Investigational Site 182
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Patients at cardiovascular risk
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
|
24 weeks (Visit 1 to Visit 3)
|
Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
|
24 weeks (Visit 1 to Visit 3)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
|
24 weeks (Visit 1 to Visit 3)
|
Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
|
24 weeks (Visit 1 to Visit 3)
|
Changes in Laboratory Parameters: Triglycerides
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
|
24 weeks (Visit 1 to Visit 3)
|
Changes in Laboratory Parameters: Blood Glucose
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
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
|
24 weeks (Visit 1 to Visit 3)
|
Assessment of Metabolic Effect
Tidsramme: 24 weeks (Visit 1 to Visit 3)
|
Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
|
24 weeks (Visit 1 to Visit 3)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 502.579
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-
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