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NCT01108796 Clinical Trial

Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

Hypertension Clinical Trial

Official title:
Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01108796
Other study ID # 502.579
Secondary ID
Status Completed
Phase N/A
First received March 11, 2010
Last updated February 28, 2014
Start date September 2008
Est. completion date September 2009

Study information
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

Clinical Trial 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.

Recruitment information / eligibility
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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Slovenia, 

Outcome
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
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