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

February 28, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Hypertension

Study Type

Observational

Enrollment (Actual)

1856

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Slovenia
- - ?adca, Slovenia
    - Boehringer Ingelheim Investigational Site 34
  - Banská Bystrica, 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
  - 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
  - Byt?a, Slovenia
    - Boehringer Ingelheim Investigational Site 33
  - Bánovce nad Bebravou, Slovenia
    - Boehringer Ingelheim Investigational Site 1
  - Dolný Kubín, Slovenia
    - Boehringer Ingelheim Investigational Site 35
  - Dubnica nad Váhom, Slovenia
    - Boehringer Ingelheim Investigational Site 36
  - Dubnica nad Váhom, Slovenia
    - Boehringer Ingelheim Investigational Site 37
  - Dunajská Streda, 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
  - Galanta, Slovenia
    - Boehringer Ingelheim Investigational Site 44
  - Galanta, Slovenia
    - Boehringer Ingelheim Investigational Site 45
  - Handlová, Slovenia
    - Boehringer Ingelheim Investigational Site 46
  - Hlohovec, Slovenia
    - Boehringer Ingelheim Investigational Site 47
  - Hlohovec, Slovenia
    - Boehringer Ingelheim Investigational Site 48
  - Hnús?a, Slovenia
    - Boehringer Ingelheim Investigational Site 49
  - Hurbanovo, Slovenia
    - Boehringer Ingelheim Investigational Site 50
  - Jesenské, Slovenia
    - Boehringer Ingelheim Investigational Site 51
  - Kezmarok, Slovenia
    - Boehringer Ingelheim Investigational Site 52
  - Kolárovo, Slovenia
    - Boehringer Ingelheim Investigational Site 53
  - Komárno, Slovenia
    - Boehringer Ingelheim Investigational Site 54
  - Komárno, Slovenia
    - Boehringer Ingelheim Investigational Site 55
  - 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
  - Kosice, Slovenia
    - Boehringer Ingelheim Investigational Site 70
  - Krá?ovský Chlmec, Slovenia
    - Boehringer Ingelheim Investigational Site 71
  - Kysucké Nové Mesto, Slovenia
    - Boehringer Ingelheim Investigational Site 72
  - Kysucké Nové Mesto, Slovenia
    - Boehringer Ingelheim Investigational Site 73
  - Kysucké Nové Mesto, Slovenia
    - Boehringer Ingelheim Investigational Site 74
  - Levice, Slovenia
    - Boehringer Ingelheim Investigational Site 75
  - Levice, Slovenia
    - Boehringer Ingelheim Investigational Site 76
  - Levice, Slovenia
    - Boehringer Ingelheim Investigational Site 77
  - Lipany, Slovenia
    - Boehringer Ingelheim Investigational Site 78
  - Lu?enec, 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
  - Martin, Slovenia
    - Boehringer Ingelheim Investigational Site 83
  - Martin, Slovenia
    - Boehringer Ingelheim Investigational Site 84
  - Martin, Slovenia
    - Boehringer Ingelheim Investigational Site 85
  - Michalovce, Slovenia
    - Boehringer Ingelheim Investigational Site 86
  - Michalovce, Slovenia
    - Boehringer Ingelheim Investigational Site 87
  - Michalovce, Slovenia
    - Boehringer Ingelheim Investigational Site 88
  - Myjava, Slovenia
    - Boehringer Ingelheim Investigational Site 89
  - Nitra, 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
  - Nové Mesto nad Váhom, 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 Zámky, 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
  - Námestovo, Slovenia
    - Boehringer Ingelheim Investigational Site 90
  - Partizánske, Slovenia
    - Boehringer Ingelheim Investigational Site 102
  - Partizánske, Slovenia
    - Boehringer Ingelheim Investigational Site 103
  - Pezinok, Slovenia
    - Boehringer Ingelheim Investigational Site 104
  - Pies?any, Slovenia
    - Boehringer Ingelheim Investigational Site 105
  - Poprad, Slovenia
    - Boehringer Ingelheim Investigational Site 106
  - Poprad, Slovenia
    - Boehringer Ingelheim Investigational Site 107
  - Poprad, Slovenia
    - Boehringer Ingelheim Investigational Site 108
  - Povazská Bystrica, Slovenia
    - Boehringer Ingelheim Investigational Site 109
  - Povazská Bystrica, Slovenia
    - Boehringer Ingelheim Investigational Site 110
  - Presov, 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
  - Prievidza, Slovenia
    - Boehringer Ingelheim Investigational Site 115
  - Prievidza, Slovenia
    - Boehringer Ingelheim Investigational Site 116
  - Prievidza, Slovenia
    - Boehringer Ingelheim Investigational Site 117
  - Rajec, Slovenia
    - Boehringer Ingelheim Investigational Site 118
  - Revúca, Slovenia
    - Boehringer Ingelheim Investigational Site 119
  - Revúca, Slovenia
    - Boehringer Ingelheim Investigational Site 120
  - Rimavská Sobota, Slovenia
    - Boehringer Ingelheim Investigational Site 121
  - Rimavská Sobota, Slovenia
    - Boehringer Ingelheim Investigational Site 122
  - Rimavská Sobota, Slovenia
    - Boehringer Ingelheim Investigational Site 123
  - Roz?ava, Slovenia
    - Boehringer Ingelheim Investigational Site 124
  - Roz?ava, Slovenia
    - Boehringer Ingelheim Investigational Site 125
  - Ruzomberok, Slovenia
    - Boehringer Ingelheim Investigational Site 126
  - Ruzomberok, Slovenia
    - Boehringer Ingelheim Investigational Site 127
  - Sa?a, Slovenia
    - Boehringer Ingelheim Investigational Site 128
  - Sa?a, Slovenia
    - Boehringer Ingelheim Investigational Site 129
  - Sa?a, Slovenia
    - Boehringer Ingelheim Investigational Site 130
  - Se?ovce, Slovenia
    - Boehringer Ingelheim Investigational Site 131
  - Se?ovce, Slovenia
    - Boehringer Ingelheim Investigational Site 132
  - Skalica, Slovenia
    - Boehringer Ingelheim Investigational Site 133
  - Snina, Slovenia
    - Boehringer Ingelheim Investigational Site 134
  - Snina, Slovenia
    - Boehringer Ingelheim Investigational Site 135
  - Spisská Nová Ves, Slovenia
    - Boehringer Ingelheim Investigational Site 136
  - Spisská Nová Ves, Slovenia
    - Boehringer Ingelheim Investigational Site 137
  - Stará ?ubov?a, Slovenia
    - Boehringer Ingelheim Investigational Site 138
  - Stará ?ubov?a, Slovenia
    - Boehringer Ingelheim Investigational Site 139
  - Stará ?ubov?a, Slovenia
    - Boehringer Ingelheim Investigational Site 140
  - Stropkov, Slovenia
    - Boehringer Ingelheim Investigational Site 141
  - Stúrovo, Slovenia
    - Boehringer Ingelheim Investigational Site 142
  - Surany, Slovenia
    - Boehringer Ingelheim Investigational Site 143
  - Surany, Slovenia
    - Boehringer Ingelheim Investigational Site 144
  - Svit, Slovenia
    - Boehringer Ingelheim Investigational Site 145
  - Topo??any, Slovenia
    - Boehringer Ingelheim Investigational Site 146
  - Torna?a, Slovenia
    - Boehringer Ingelheim Investigational Site 147
  - Trebisov, Slovenia
    - Boehringer Ingelheim Investigational Site 148
  - Trebisov, Slovenia
    - Boehringer Ingelheim Investigational Site 149
  - Trebisov, Slovenia
    - Boehringer Ingelheim Investigational Site 150
  - Tren?ín, 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
  - Trnava, 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
  - Trstená, Slovenia
    - Boehringer Ingelheim Investigational Site 159
  - Tur?ianske Teplice, Slovenia
    - Boehringer Ingelheim Investigational Site 160
  - Turzovka, Slovenia
    - Boehringer Ingelheim Investigational Site 161
  - Ve?ké Kapusany, Slovenia
    - Boehringer Ingelheim Investigational Site 162
  - Ve?ké Kapusany, Slovenia
    - Boehringer Ingelheim Investigational Site 163
  - Ve?ký Krtís, Slovenia
    - Boehringer Ingelheim Investigational Site 164
  - Ve?ký Krtís, Slovenia
    - Boehringer Ingelheim Investigational Site 165
  - Vranov nad Top?ou, Slovenia
    - Boehringer Ingelheim Investigational Site 167
  - Vráble, Slovenia
    - Boehringer Ingelheim Investigational Site 166
  - Zarnovica, Slovenia
    - Boehringer Ingelheim Investigational Site 168
  - Zeliezovce, Slovenia
    - Boehringer Ingelheim Investigational Site 169
  - Zilina, 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
  - Zlaté Moravce, Slovenia
    - Boehringer Ingelheim Investigational Site 176
  - Zlaté Moravce, Slovenia
    - Boehringer Ingelheim Investigational Site 177
  - Zlaté Moravce, Slovenia
    - Boehringer Ingelheim Investigational Site 178
  - Zvolen, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with hypertension

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients at cardiovascular risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline Time Frame: 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 Time Frame: 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) Time Frame: 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) Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

502.579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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