Clinical trial NCT01108796: Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
Official title: Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 1856
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hypertension

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

1. 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)
2. Patients with hypertension under treatment with one or more antihypertensive drug

Exclusion criteria:

Patients are excluded according to the summary of product characteristics (SmPC).

Primary outcomes:
measure: Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
timeFrame: 24 weeks (Visit 1 to Visit 3)
measure: Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
timeFrame: 24 weeks (Visit 1 to Visit 3)
Secondary outcomes:
measure: Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
timeFrame: 24 weeks (Visit 1 to Visit 3)
measure: Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
timeFrame: 24 weeks (Visit 1 to Visit 3)
measure: Changes in Laboratory Parameters: Triglycerides
timeFrame: 24 weeks (Visit 1 to Visit 3)
measure: Changes in Laboratory Parameters: Blood Glucose
timeFrame: 24 weeks (Visit 1 to Visit 3)
measure: Assessment of Metabolic Effect
timeFrame: 24 weeks (Visit 1 to Visit 3)
Other outcomes:
Locations:
city: ?adca
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 34
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 2
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 3
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 4
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 5
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 6
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 7
city: Banská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 8
city: Bardejov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 10
city: Bardejov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 11
city: Bardejov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 12
city: Bardejov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 9
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 13
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 14
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 15
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 16
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 17
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 18
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 19
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 20
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 21
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 22
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 23
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 24
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 25
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 26
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 27
city: Bratislava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 28
city: Brezno
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 29
city: Brezno
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 30
city: Brezno
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 31
city: Brezno
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 32
city: Byt?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 33
city: Bánovce nad Bebravou
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 1
city: Dolný Kubín
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 35
city: Dubnica nad Váhom
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 36
city: Dubnica nad Váhom
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 37
city: Dunajská Streda
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 38
city: Dunajská Streda
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 39
city: Dunajská Streda
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 40
city: Dunajská Streda
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 41
city: Dunajská Streda
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 42
city: Dunajská Streda
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 43
city: Galanta
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 44
city: Galanta
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 45
city: Handlová
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 46
city: Hlohovec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 47
city: Hlohovec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 48
city: Hnús?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 49
city: Hurbanovo
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 50
city: Jesenské
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 51
city: Kezmarok
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 52
city: Kolárovo
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 53
city: Komárno
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 54
city: Komárno
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 55
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 56
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 57
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 58
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 59
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 60
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 61
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 62
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 63
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 64
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 65
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 66
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 67
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 68
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 69
city: Kosice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 70
city: Krá?ovský Chlmec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 71
city: Kysucké Nové Mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 72
city: Kysucké Nové Mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 73
city: Kysucké Nové Mesto
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 74
city: Levice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 75
city: Levice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 76
city: Levice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 77
city: Lipany
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 78
city: Lu?enec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 79
city: Lu?enec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 80
city: Lu?enec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 81
city: Lu?enec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 82
city: Martin
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 83
city: Martin
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 84
city: Martin
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 85
city: Michalovce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 86
city: Michalovce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 87
city: Michalovce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 88
city: Myjava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 89
city: Nitra
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 91
city: Nitra
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 92
city: Nitra
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 93
city: Nitra
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 94
city: Nové Mesto nad Váhom
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 95
city: Nové Mesto nad Váhom
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 96
city: Nové Mesto nad Váhom
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 97
city: Nové Zámky
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 100
city: Nové Zámky
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 101
city: Nové Zámky
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 98
city: Nové Zámky
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 99
city: Námestovo
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 90
city: Partizánske
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 102
city: Partizánske
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 103
city: Pezinok
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 104
city: Pies?any
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 105
city: Poprad
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 106
city: Poprad
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 107
city: Poprad
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 108
city: Povazská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 109
city: Povazská Bystrica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 110
city: Presov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 111
city: Presov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 112
city: Presov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 113
city: Presov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 114
city: Prievidza
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 115
city: Prievidza
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 116
city: Prievidza
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 117
city: Rajec
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 118
city: Revúca
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 119
city: Revúca
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 120
city: Rimavská Sobota
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 121
city: Rimavská Sobota
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 122
city: Rimavská Sobota
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 123
city: Roz?ava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 124
city: Roz?ava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 125
city: Ruzomberok
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 126
city: Ruzomberok
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 127
city: Sa?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 128
city: Sa?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 129
city: Sa?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 130
city: Se?ovce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 131
city: Se?ovce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 132
city: Skalica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 133
city: Snina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 134
city: Snina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 135
city: Spisská Nová Ves
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 136
city: Spisská Nová Ves
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 137
city: Stará ?ubov?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 138
city: Stará ?ubov?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 139
city: Stará ?ubov?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 140
city: Stropkov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 141
city: Stúrovo
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 142
city: Surany
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 143
city: Surany
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 144
city: Svit
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 145
city: Topo??any
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 146
city: Torna?a
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 147
city: Trebisov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 148
city: Trebisov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 149
city: Trebisov
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 150
city: Tren?ín
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 151
city: Tren?ín
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 152
city: Tren?ín
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 153
city: Tren?ín
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 154
city: Trnava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 155
city: Trnava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 156
city: Trnava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 157
city: Trnava
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 158
city: Trstená
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 159
city: Tur?ianske Teplice
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 160
city: Turzovka
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 161
city: Ve?ké Kapusany
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 162
city: Ve?ké Kapusany
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 163
city: Ve?ký Krtís
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 164
city: Ve?ký Krtís
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 165
city: Vranov nad Top?ou
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 167
city: Vráble
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 166
city: Zarnovica
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 168
city: Zeliezovce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 169
city: Zilina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 170
city: Zilina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 171
city: Zilina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 172
city: Zilina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 173
city: Zilina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 174
city: Zilina
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 175
city: Zlaté Moravce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 176
city: Zlaté Moravce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 177
city: Zlaté Moravce
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 178
city: Zvolen
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 179
city: Zvolen
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 180
city: Zvolen
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 181
city: Zvolen
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 182
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: