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

NCT01108796 | Completed Results

• 1 other identifier: 502.579
• Study Type: observational
• Target: 1,856
• Locations: 1 country
• Sites: 182

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (5)

• Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)

  24 weeks (Visit 1 to Visit 3)

• Changes in Laboratory Parameters:High Density Lipoprotein (HDL)

  24 weeks (Visit 1 to Visit 3)

• Changes in Laboratory Parameters: Triglycerides

  24 weeks (Visit 1 to Visit 3)

• Changes in Laboratory Parameters: Blood Glucose

  24 weeks (Visit 1 to Visit 3)

• Assessment of Metabolic Effect

  24 weeks (Visit 1 to Visit 3)

Study Arms (1)

Patients at cardiovascular risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hypertension

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (182)

Boehringer Ingelheim Investigational Site 34

?adca, Slovenia

Location

Boehringer Ingelheim Investigational Site 2

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 3

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 4

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 5

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 6

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 7

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 8

Banská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 10

Bardejov, Slovenia

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Boehringer Ingelheim Investigational Site 11

Bardejov, Slovenia

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Boehringer Ingelheim Investigational Site 12

Bardejov, Slovenia

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Boehringer Ingelheim Investigational Site 9

Bardejov, Slovenia

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Boehringer Ingelheim Investigational Site 1

Bánovce Nad Bebravou, Slovenia

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Boehringer Ingelheim Investigational Site 13

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 14

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 15

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 16

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 17

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 18

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 19

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 20

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 21

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 22

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 23

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 24

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 25

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 26

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 27

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 28

Bratislava, Slovenia

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Boehringer Ingelheim Investigational Site 29

Brezno, Slovenia

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Boehringer Ingelheim Investigational Site 30

Brezno, Slovenia

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Boehringer Ingelheim Investigational Site 31

Brezno, Slovenia

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Boehringer Ingelheim Investigational Site 32

Brezno, Slovenia

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Boehringer Ingelheim Investigational Site 33

Byt?a, Slovenia

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Boehringer Ingelheim Investigational Site 35

Dolný Kubín, Slovenia

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Boehringer Ingelheim Investigational Site 36

Dubnica Nad Váhom, Slovenia

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Boehringer Ingelheim Investigational Site 37

Dubnica Nad Váhom, Slovenia

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Boehringer Ingelheim Investigational Site 38

Dunajská Streda, Slovenia

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Boehringer Ingelheim Investigational Site 39

Dunajská Streda, Slovenia

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Boehringer Ingelheim Investigational Site 40

Dunajská Streda, Slovenia

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Boehringer Ingelheim Investigational Site 41

Dunajská Streda, Slovenia

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Boehringer Ingelheim Investigational Site 42

Dunajská Streda, Slovenia

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Boehringer Ingelheim Investigational Site 43

Dunajská Streda, Slovenia

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Boehringer Ingelheim Investigational Site 44

Galanta, Slovenia

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Boehringer Ingelheim Investigational Site 45

Galanta, Slovenia

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Boehringer Ingelheim Investigational Site 46

Handlová, Slovenia

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Boehringer Ingelheim Investigational Site 47

Hlohovec, Slovenia

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Boehringer Ingelheim Investigational Site 48

Hlohovec, Slovenia

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Boehringer Ingelheim Investigational Site 49

Hnús?a, Slovenia

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Boehringer Ingelheim Investigational Site 50

Hurbanovo, Slovenia

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Boehringer Ingelheim Investigational Site 51

Jesenské, Slovenia

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Boehringer Ingelheim Investigational Site 52

Kezmarok, Slovenia

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Boehringer Ingelheim Investigational Site 53

Kolárovo, Slovenia

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Boehringer Ingelheim Investigational Site 54

Komárno, Slovenia

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Boehringer Ingelheim Investigational Site 55

Komárno, Slovenia

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Boehringer Ingelheim Investigational Site 56

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 57

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 58

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 59

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 60

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 61

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 62

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 63

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 64

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 65

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 66

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 67

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 68

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 69

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 70

Kosice, Slovenia

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Boehringer Ingelheim Investigational Site 71

Krá?ovský Chlmec, Slovenia

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Boehringer Ingelheim Investigational Site 72

Kysucké Nové Mesto, Slovenia

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Boehringer Ingelheim Investigational Site 73

Kysucké Nové Mesto, Slovenia

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Boehringer Ingelheim Investigational Site 74

Kysucké Nové Mesto, Slovenia

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Boehringer Ingelheim Investigational Site 75

Levice, Slovenia

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Boehringer Ingelheim Investigational Site 76

Levice, Slovenia

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Boehringer Ingelheim Investigational Site 77

Levice, Slovenia

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Boehringer Ingelheim Investigational Site 78

Lipany, Slovenia

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Boehringer Ingelheim Investigational Site 79

Lu?enec, Slovenia

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Boehringer Ingelheim Investigational Site 80

Lu?enec, Slovenia

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Boehringer Ingelheim Investigational Site 81

Lu?enec, Slovenia

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Boehringer Ingelheim Investigational Site 82

Lu?enec, Slovenia

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Boehringer Ingelheim Investigational Site 83

Martin, Slovenia

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Boehringer Ingelheim Investigational Site 84

Martin, Slovenia

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Boehringer Ingelheim Investigational Site 85

Martin, Slovenia

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Boehringer Ingelheim Investigational Site 86

Michalovce, Slovenia

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Boehringer Ingelheim Investigational Site 87

Michalovce, Slovenia

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Boehringer Ingelheim Investigational Site 88

Michalovce, Slovenia

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Boehringer Ingelheim Investigational Site 89

Myjava, Slovenia

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Boehringer Ingelheim Investigational Site 90

Námestovo, Slovenia

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Boehringer Ingelheim Investigational Site 91

Nitra, Slovenia

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Boehringer Ingelheim Investigational Site 92

Nitra, Slovenia

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Boehringer Ingelheim Investigational Site 93

Nitra, Slovenia

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Boehringer Ingelheim Investigational Site 94

Nitra, Slovenia

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Boehringer Ingelheim Investigational Site 95

Nové Mesto Nad Váhom, Slovenia

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Boehringer Ingelheim Investigational Site 96

Nové Mesto Nad Váhom, Slovenia

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Boehringer Ingelheim Investigational Site 97

Nové Mesto Nad Váhom, Slovenia

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Boehringer Ingelheim Investigational Site 100

Nové Zámky, Slovenia

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Boehringer Ingelheim Investigational Site 101

Nové Zámky, Slovenia

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Boehringer Ingelheim Investigational Site 98

Nové Zámky, Slovenia

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Boehringer Ingelheim Investigational Site 99

Nové Zámky, Slovenia

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Boehringer Ingelheim Investigational Site 102

Partizánske, Slovenia

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Boehringer Ingelheim Investigational Site 103

Partizánske, Slovenia

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Boehringer Ingelheim Investigational Site 104

Pezinok, Slovenia

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Boehringer Ingelheim Investigational Site 105

Pies?any, Slovenia

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Boehringer Ingelheim Investigational Site 106

Poprad, Slovenia

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Boehringer Ingelheim Investigational Site 107

Poprad, Slovenia

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Boehringer Ingelheim Investigational Site 108

Poprad, Slovenia

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Boehringer Ingelheim Investigational Site 109

Povazská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 110

Povazská Bystrica, Slovenia

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Boehringer Ingelheim Investigational Site 111

Presov, Slovenia

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Boehringer Ingelheim Investigational Site 112

Presov, Slovenia

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Boehringer Ingelheim Investigational Site 113

Presov, Slovenia

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Boehringer Ingelheim Investigational Site 114

Presov, Slovenia

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Boehringer Ingelheim Investigational Site 115

Prievidza, Slovenia

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Boehringer Ingelheim Investigational Site 116

Prievidza, Slovenia

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Boehringer Ingelheim Investigational Site 117

Prievidza, Slovenia

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Boehringer Ingelheim Investigational Site 118

Rajec, Slovenia

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Boehringer Ingelheim Investigational Site 119

Revúca, Slovenia

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Boehringer Ingelheim Investigational Site 120

Revúca, Slovenia

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Boehringer Ingelheim Investigational Site 121

Rimavská Sobota, Slovenia

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Boehringer Ingelheim Investigational Site 122

Rimavská Sobota, Slovenia

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Boehringer Ingelheim Investigational Site 123

Rimavská Sobota, Slovenia

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Boehringer Ingelheim Investigational Site 124

Roz?ava, Slovenia

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Boehringer Ingelheim Investigational Site 125

Roz?ava, Slovenia

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Boehringer Ingelheim Investigational Site 126

Ruzomberok, Slovenia

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Boehringer Ingelheim Investigational Site 127

Ruzomberok, Slovenia

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Boehringer Ingelheim Investigational Site 128

Sa?a, Slovenia

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Boehringer Ingelheim Investigational Site 129

Sa?a, Slovenia

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Boehringer Ingelheim Investigational Site 130

Sa?a, Slovenia

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Boehringer Ingelheim Investigational Site 131

Se?ovce, Slovenia

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Boehringer Ingelheim Investigational Site 132

Se?ovce, Slovenia

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Boehringer Ingelheim Investigational Site 133

Skalica, Slovenia

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Boehringer Ingelheim Investigational Site 134

Snina, Slovenia

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Boehringer Ingelheim Investigational Site 135

Snina, Slovenia

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Boehringer Ingelheim Investigational Site 136

Spisská Nová Ves, Slovenia

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Boehringer Ingelheim Investigational Site 137

Spisská Nová Ves, Slovenia

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Boehringer Ingelheim Investigational Site 138

Stará ?ubov?a, Slovenia

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Boehringer Ingelheim Investigational Site 139

Stará ?ubov?a, Slovenia

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Boehringer Ingelheim Investigational Site 140

Stará ?ubov?a, Slovenia

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Boehringer Ingelheim Investigational Site 141

Stropkov, Slovenia

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Boehringer Ingelheim Investigational Site 142

Stúrovo, Slovenia

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Boehringer Ingelheim Investigational Site 143

Surany, Slovenia

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Boehringer Ingelheim Investigational Site 144

Surany, Slovenia

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Boehringer Ingelheim Investigational Site 145

Svit, Slovenia

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Boehringer Ingelheim Investigational Site 146

Topo??any, Slovenia

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Boehringer Ingelheim Investigational Site 147

Torna?a, Slovenia

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Boehringer Ingelheim Investigational Site 148

Trebisov, Slovenia

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Boehringer Ingelheim Investigational Site 149

Trebisov, Slovenia

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Boehringer Ingelheim Investigational Site 150

Trebisov, Slovenia

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Boehringer Ingelheim Investigational Site 151

Tren?ín, Slovenia

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Boehringer Ingelheim Investigational Site 152

Tren?ín, Slovenia

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Boehringer Ingelheim Investigational Site 153

Tren?ín, Slovenia

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Boehringer Ingelheim Investigational Site 154

Tren?ín, Slovenia

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Boehringer Ingelheim Investigational Site 155

Trnava, Slovenia

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Boehringer Ingelheim Investigational Site 156

Trnava, Slovenia

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Boehringer Ingelheim Investigational Site 157

Trnava, Slovenia

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Boehringer Ingelheim Investigational Site 158

Trnava, Slovenia

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Boehringer Ingelheim Investigational Site 159

Trstená, Slovenia

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Boehringer Ingelheim Investigational Site 160

Tur?ianske Teplice, Slovenia

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Boehringer Ingelheim Investigational Site 161

Turzovka, Slovenia

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Boehringer Ingelheim Investigational Site 162

Ve?ké Kapusany, Slovenia

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Boehringer Ingelheim Investigational Site 163

Ve?ké Kapusany, Slovenia

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Boehringer Ingelheim Investigational Site 164

Ve?ký Krtís, Slovenia

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Boehringer Ingelheim Investigational Site 165

Ve?ký Krtís, Slovenia

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Boehringer Ingelheim Investigational Site 167

Vranov Nad Top?ou, Slovenia

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Boehringer Ingelheim Investigational Site 166

Vráble, Slovenia

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Boehringer Ingelheim Investigational Site 168

Zarnovica, Slovenia

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Boehringer Ingelheim Investigational Site 169

Zeliezovce, Slovenia

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Boehringer Ingelheim Investigational Site 170

Zilina, Slovenia

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Boehringer Ingelheim Investigational Site 171

Zilina, Slovenia

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Boehringer Ingelheim Investigational Site 172

Zilina, Slovenia

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Boehringer Ingelheim Investigational Site 173

Zilina, Slovenia

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Boehringer Ingelheim Investigational Site 174

Zilina, Slovenia

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Boehringer Ingelheim Investigational Site 175

Zilina, Slovenia

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Boehringer Ingelheim Investigational Site 176

Zlaté Moravce, Slovenia

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Boehringer Ingelheim Investigational Site 177

Zlaté Moravce, Slovenia

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Boehringer Ingelheim Investigational Site 178

Zlaté Moravce, Slovenia

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Boehringer Ingelheim Investigational Site 179

Zvolen, Slovenia

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Boehringer Ingelheim Investigational Site 180

Zvolen, Slovenia

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Boehringer Ingelheim Investigational Site 181

Zvolen, Slovenia

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Boehringer Ingelheim Investigational Site 182

Zvolen, Slovenia

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: April 22, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 10, 2014
• Results First Posted: December 30, 2011

Record last verified: 2014-02

Locations

SL (182)