Hypertension Clinical Trial
Official title:
Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan
Verified date | February 2014 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovakia: State Institute for Drug Control |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1856 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovenia | Boehringer Ingelheim Investigational Site 34 | ?adca | |
Slovenia | Boehringer Ingelheim Investigational Site 1 | Bánovce nad Bebravou | |
Slovenia | Boehringer Ingelheim Investigational Site 2 | Banská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 3 | Banská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 4 | Banská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 5 | Banská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 6 | Banská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 7 | Banská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 8 | Banská Bystrica | |
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 | Bardejov | |
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 | Bratislava | |
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 | Brezno | |
Slovenia | Boehringer Ingelheim Investigational Site 33 | Byt?a | |
Slovenia | Boehringer Ingelheim Investigational Site 35 | Dolný Kubín | |
Slovenia | Boehringer Ingelheim Investigational Site 36 | Dubnica nad Váhom | |
Slovenia | Boehringer Ingelheim Investigational Site 37 | Dubnica nad Váhom | |
Slovenia | Boehringer Ingelheim Investigational Site 38 | Dunajská Streda | |
Slovenia | Boehringer Ingelheim Investigational Site 39 | Dunajská Streda | |
Slovenia | Boehringer Ingelheim Investigational Site 40 | Dunajská Streda | |
Slovenia | Boehringer Ingelheim Investigational Site 41 | Dunajská Streda | |
Slovenia | Boehringer Ingelheim Investigational Site 42 | Dunajská Streda | |
Slovenia | Boehringer Ingelheim Investigational Site 43 | Dunajská Streda | |
Slovenia | Boehringer Ingelheim Investigational Site 44 | Galanta | |
Slovenia | Boehringer Ingelheim Investigational Site 45 | Galanta | |
Slovenia | Boehringer Ingelheim Investigational Site 46 | Handlová | |
Slovenia | Boehringer Ingelheim Investigational Site 47 | Hlohovec | |
Slovenia | Boehringer Ingelheim Investigational Site 48 | Hlohovec | |
Slovenia | Boehringer Ingelheim Investigational Site 49 | Hnús?a | |
Slovenia | Boehringer Ingelheim Investigational Site 50 | Hurbanovo | |
Slovenia | Boehringer Ingelheim Investigational Site 51 | Jesenské | |
Slovenia | Boehringer Ingelheim Investigational Site 52 | Kezmarok | |
Slovenia | Boehringer Ingelheim Investigational Site 53 | Kolárovo | |
Slovenia | Boehringer Ingelheim Investigational Site 54 | Komárno | |
Slovenia | Boehringer Ingelheim Investigational Site 55 | Komárno | |
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 | Kosice | |
Slovenia | Boehringer Ingelheim Investigational Site 70 | Kosice | |
Slovenia | Boehringer Ingelheim Investigational Site 71 | Krá?ovský Chlmec | |
Slovenia | Boehringer Ingelheim Investigational Site 72 | Kysucké Nové Mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 73 | Kysucké Nové Mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 74 | Kysucké Nové Mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 75 | Levice | |
Slovenia | Boehringer Ingelheim Investigational Site 76 | Levice | |
Slovenia | Boehringer Ingelheim Investigational Site 77 | Levice | |
Slovenia | Boehringer Ingelheim Investigational Site 78 | Lipany | |
Slovenia | Boehringer Ingelheim Investigational Site 79 | Lu?enec | |
Slovenia | Boehringer Ingelheim Investigational Site 80 | Lu?enec | |
Slovenia | Boehringer Ingelheim Investigational Site 81 | Lu?enec | |
Slovenia | Boehringer Ingelheim Investigational Site 82 | Lu?enec | |
Slovenia | Boehringer Ingelheim Investigational Site 83 | Martin | |
Slovenia | Boehringer Ingelheim Investigational Site 84 | Martin | |
Slovenia | Boehringer Ingelheim Investigational Site 85 | Martin | |
Slovenia | Boehringer Ingelheim Investigational Site 86 | Michalovce | |
Slovenia | Boehringer Ingelheim Investigational Site 87 | Michalovce | |
Slovenia | Boehringer Ingelheim Investigational Site 88 | Michalovce | |
Slovenia | Boehringer Ingelheim Investigational Site 89 | Myjava | |
Slovenia | Boehringer Ingelheim Investigational Site 90 | Námestovo | |
Slovenia | Boehringer Ingelheim Investigational Site 91 | Nitra | |
Slovenia | Boehringer Ingelheim Investigational Site 92 | Nitra | |
Slovenia | Boehringer Ingelheim Investigational Site 93 | Nitra | |
Slovenia | Boehringer Ingelheim Investigational Site 94 | Nitra | |
Slovenia | Boehringer Ingelheim Investigational Site 95 | Nové Mesto nad Váhom | |
Slovenia | Boehringer Ingelheim Investigational Site 96 | Nové Mesto nad Váhom | |
Slovenia | Boehringer Ingelheim Investigational Site 97 | Nové Mesto nad Váhom | |
Slovenia | Boehringer Ingelheim Investigational Site 100 | Nové Zámky | |
Slovenia | Boehringer Ingelheim Investigational Site 101 | Nové Zámky | |
Slovenia | Boehringer Ingelheim Investigational Site 98 | Nové Zámky | |
Slovenia | Boehringer Ingelheim Investigational Site 99 | Nové Zámky | |
Slovenia | Boehringer Ingelheim Investigational Site 102 | Partizánske | |
Slovenia | Boehringer Ingelheim Investigational Site 103 | Partizánske | |
Slovenia | Boehringer Ingelheim Investigational Site 104 | Pezinok | |
Slovenia | Boehringer Ingelheim Investigational Site 105 | Pies?any | |
Slovenia | Boehringer Ingelheim Investigational Site 106 | Poprad | |
Slovenia | Boehringer Ingelheim Investigational Site 107 | Poprad | |
Slovenia | Boehringer Ingelheim Investigational Site 108 | Poprad | |
Slovenia | Boehringer Ingelheim Investigational Site 109 | Povazská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 110 | Povazská Bystrica | |
Slovenia | Boehringer Ingelheim Investigational Site 111 | Presov | |
Slovenia | Boehringer Ingelheim Investigational Site 112 | Presov | |
Slovenia | Boehringer Ingelheim Investigational Site 113 | Presov | |
Slovenia | Boehringer Ingelheim Investigational Site 114 | Presov | |
Slovenia | Boehringer Ingelheim Investigational Site 115 | Prievidza | |
Slovenia | Boehringer Ingelheim Investigational Site 116 | Prievidza | |
Slovenia | Boehringer Ingelheim Investigational Site 117 | Prievidza | |
Slovenia | Boehringer Ingelheim Investigational Site 118 | Rajec | |
Slovenia | Boehringer Ingelheim Investigational Site 119 | Revúca | |
Slovenia | Boehringer Ingelheim Investigational Site 120 | Revúca | |
Slovenia | Boehringer Ingelheim Investigational Site 121 | Rimavská Sobota | |
Slovenia | Boehringer Ingelheim Investigational Site 122 | Rimavská Sobota | |
Slovenia | Boehringer Ingelheim Investigational Site 123 | Rimavská Sobota | |
Slovenia | Boehringer Ingelheim Investigational Site 124 | Roz?ava | |
Slovenia | Boehringer Ingelheim Investigational Site 125 | Roz?ava | |
Slovenia | Boehringer Ingelheim Investigational Site 126 | Ruzomberok | |
Slovenia | Boehringer Ingelheim Investigational Site 127 | Ruzomberok | |
Slovenia | Boehringer Ingelheim Investigational Site 128 | Sa?a | |
Slovenia | Boehringer Ingelheim Investigational Site 129 | Sa?a | |
Slovenia | Boehringer Ingelheim Investigational Site 130 | Sa?a | |
Slovenia | Boehringer Ingelheim Investigational Site 131 | Se?ovce | |
Slovenia | Boehringer Ingelheim Investigational Site 132 | Se?ovce | |
Slovenia | Boehringer Ingelheim Investigational Site 133 | Skalica | |
Slovenia | Boehringer Ingelheim Investigational Site 134 | Snina | |
Slovenia | Boehringer Ingelheim Investigational Site 135 | Snina | |
Slovenia | Boehringer Ingelheim Investigational Site 136 | Spisská Nová Ves | |
Slovenia | Boehringer Ingelheim Investigational Site 137 | Spisská Nová Ves | |
Slovenia | Boehringer Ingelheim Investigational Site 138 | Stará ?ubov?a | |
Slovenia | Boehringer Ingelheim Investigational Site 139 | Stará ?ubov?a | |
Slovenia | Boehringer Ingelheim Investigational Site 140 | Stará ?ubov?a | |
Slovenia | Boehringer Ingelheim Investigational Site 141 | Stropkov | |
Slovenia | Boehringer Ingelheim Investigational Site 142 | Stúrovo | |
Slovenia | Boehringer Ingelheim Investigational Site 143 | Surany | |
Slovenia | Boehringer Ingelheim Investigational Site 144 | Surany | |
Slovenia | Boehringer Ingelheim Investigational Site 145 | Svit | |
Slovenia | Boehringer Ingelheim Investigational Site 146 | Topo??any | |
Slovenia | Boehringer Ingelheim Investigational Site 147 | Torna?a | |
Slovenia | Boehringer Ingelheim Investigational Site 148 | Trebisov | |
Slovenia | Boehringer Ingelheim Investigational Site 149 | Trebisov | |
Slovenia | Boehringer Ingelheim Investigational Site 150 | Trebisov | |
Slovenia | Boehringer Ingelheim Investigational Site 151 | Tren?ín | |
Slovenia | Boehringer Ingelheim Investigational Site 152 | Tren?ín | |
Slovenia | Boehringer Ingelheim Investigational Site 153 | Tren?ín | |
Slovenia | Boehringer Ingelheim Investigational Site 154 | Tren?ín | |
Slovenia | Boehringer Ingelheim Investigational Site 155 | Trnava | |
Slovenia | Boehringer Ingelheim Investigational Site 156 | Trnava | |
Slovenia | Boehringer Ingelheim Investigational Site 157 | Trnava | |
Slovenia | Boehringer Ingelheim Investigational Site 158 | Trnava | |
Slovenia | Boehringer Ingelheim Investigational Site 159 | Trstená | |
Slovenia | Boehringer Ingelheim Investigational Site 160 | Tur?ianske Teplice | |
Slovenia | Boehringer Ingelheim Investigational Site 161 | Turzovka | |
Slovenia | Boehringer Ingelheim Investigational Site 162 | Ve?ké Kapusany | |
Slovenia | Boehringer Ingelheim Investigational Site 163 | Ve?ké Kapusany | |
Slovenia | Boehringer Ingelheim Investigational Site 164 | Ve?ký Krtís | |
Slovenia | Boehringer Ingelheim Investigational Site 165 | Ve?ký Krtís | |
Slovenia | Boehringer Ingelheim Investigational Site 166 | Vráble | |
Slovenia | Boehringer Ingelheim Investigational Site 167 | Vranov nad Top?ou | |
Slovenia | Boehringer Ingelheim Investigational Site 168 | Zarnovica | |
Slovenia | Boehringer Ingelheim Investigational Site 169 | Zeliezovce | |
Slovenia | Boehringer Ingelheim Investigational Site 170 | Zilina | |
Slovenia | Boehringer Ingelheim Investigational Site 171 | Zilina | |
Slovenia | Boehringer Ingelheim Investigational Site 172 | Zilina | |
Slovenia | Boehringer Ingelheim Investigational Site 173 | Zilina | |
Slovenia | Boehringer Ingelheim Investigational Site 174 | Zilina | |
Slovenia | Boehringer Ingelheim Investigational Site 175 | Zilina | |
Slovenia | Boehringer Ingelheim Investigational Site 176 | Zlaté Moravce | |
Slovenia | Boehringer Ingelheim Investigational Site 177 | Zlaté Moravce | |
Slovenia | Boehringer Ingelheim Investigational Site 178 | Zlaté Moravce | |
Slovenia | Boehringer Ingelheim Investigational Site 179 | Zvolen | |
Slovenia | Boehringer Ingelheim Investigational Site 180 | Zvolen | |
Slovenia | Boehringer Ingelheim Investigational Site 181 | Zvolen | |
Slovenia | Boehringer Ingelheim Investigational Site 182 | Zvolen |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | 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) | No |
Primary | Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | 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) | No |
Secondary | Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) | 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) | No |
Secondary | Changes in Laboratory Parameters:High Density Lipoprotein (HDL) | 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) | No |
Secondary | Changes in Laboratory Parameters: Triglycerides | 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) | No |
Secondary | Changes in Laboratory Parameters: Blood Glucose | 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) | No |
Secondary | Assessment of Metabolic Effect | Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative' | 24 weeks (Visit 1 to Visit 3) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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