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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01108796
First received: March 11, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool

  • Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool


Secondary Outcome Measures:
  • Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  • Changes in Laboratory Parameters:High Density Lipoprotein (HDL) [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  • Changes in Laboratory Parameters: Triglycerides [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  • Changes in Laboratory Parameters: Blood Glucose [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    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

  • Assessment of Metabolic Effect [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'


Enrollment: 1856
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients at cardiovascular risk

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with hypertension

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108796

  Hide Study Locations
Locations
Slovenia
Boehringer Ingelheim Investigational Site 34
?adca, 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 9
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 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 1
Bánovce nad Bebravou, 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 67
Kosice, Slovenia
Boehringer Ingelheim Investigational Site 68
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 57
Kosice, Slovenia
Boehringer Ingelheim Investigational Site 58
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 92
Nitra, Slovenia
Boehringer Ingelheim Investigational Site 91
Nitra, Slovenia
Boehringer Ingelheim Investigational Site 94
Nitra, Slovenia
Boehringer Ingelheim Investigational Site 93
Nitra, Slovenia
Boehringer Ingelheim Investigational Site 97
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 98
Nové Zámky, Slovenia
Boehringer Ingelheim Investigational Site 99
Nové Zámky, Slovenia
Boehringer Ingelheim Investigational Site 101
Nové Zámky, Slovenia
Boehringer Ingelheim Investigational Site 100
Nové Zámky, Slovenia
Boehringer Ingelheim Investigational Site 90
Námestovo, 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 167
Vranov nad Top?ou, Slovenia
Boehringer Ingelheim Investigational Site 166
Vráble, 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, Slovenia
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01108796     History of Changes
Other Study ID Numbers: 502.579
Study First Received: March 11, 2010
Results First Received: September 1, 2011
Last Updated: February 28, 2014
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Telmisartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014