PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg

NCT00936208 | Completed Results

• 1 other identifier: 502.584
• Study Type: observational
• Target: 3,184
• Locations: 3 countries
• Sites: 120

Brief Summary

PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients will have essential hypertension. In addition, the patients will have at least one other contributing risk factor for cardiovascular events. The study aims to evaluate the safety, efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in patients with essential hypertension

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in Diastolic Blood Pressure From Baseline at Week 24

  The change from baseline reflects the week 24 value minus the baseline value.

  Baseline and Week 24

• Change in Systolic Blood Pressure From Baseline at Week 24

  The change from baseline reflects the week 24 value minus the baseline value.

  Baseline and Week 24

Secondary Outcomes (5)

• Framingham Score at Week 24

  Week 24

• Change in the Framingham Score From Baseline at Week 24

  Baseline and Week 24

• International Renal Interest Society (IRIS) II Score at Week 24

  Week 24

• Change in the IRIS II Score From Baseline at Week 24

  Baseline and Week 24

• Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)

  Baseline and Week 24

Study Arms (1)

Essential hypertensive men and women

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates

You may qualify if:

• Male or female
• Aged 20 to 80 years old.
• adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled
• Sitting blood pressure: systolic BP \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg)
• At least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as \> 55 years (Males), \> 65 years (Females), smoking, overweight or obese patients or a combination of above risk factors
• Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication

You may not qualify if:

• Patients with contraindications to Telmisartan use (as per the Micardis® Tablets package insert).
• Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® .
• Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
• Patients participating in any other clinical trial.
• Patients already on Micardis® alone or combination
• Pregnant females, or females breast feeding.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (120)

Boehringer Ingelheim Investigational Site 28

Al Fayyum, Egypt

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Boehringer Ingelheim Investigational Site 18

Alexandria, Egypt

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Boehringer Ingelheim Investigational Site 19

Alexandria, Egypt

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Boehringer Ingelheim Investigational Site 20

Alexandria, Egypt

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Boehringer Ingelheim Investigational Site 21

Alexandria, Egypt

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Boehringer Ingelheim Investigational Site 16

Alexandria West, Egypt

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Boehringer Ingelheim Investigational Site 17

Alexandria West, Egypt

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Boehringer Ingelheim Investigational Site 29

Asyut, Egypt

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Boehringer Ingelheim Investigational Site 10

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 11

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 12

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 1

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 2

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 3

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 4

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 5

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 6

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 7

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 8

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 9

Cairo, Egypt

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Boehringer Ingelheim Investigational Site 22

Domiat, Egypt

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Boehringer Ingelheim Investigational Site 23

El Garbia, Egypt

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Boehringer Ingelheim Investigational Site 25

Fakous - El Sharkia, Egypt

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Boehringer Ingelheim Investigational Site 13

Kalioubya, Egypt

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Boehringer Ingelheim Investigational Site 27

Mansoura - El Dakahlia, Egypt

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Boehringer Ingelheim Investigational Site 30

Menofia, Egypt

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Boehringer Ingelheim Investigational Site 14

Minya, Egypt

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Boehringer Ingelheim Investigational Site 15

Minya, Egypt

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Boehringer Ingelheim Investigational Site 24

Poert Said, Egypt

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Boehringer Ingelheim Investigational Site 26

Zagazig - El Sharkia, Egypt

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Boehringer Ingelheim Investigational Site 100

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 101

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 92

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 93

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 94

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 95

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 96

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 97

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 98

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 99

Eastern Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 31

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 32

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 33

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 34

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 35

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 36

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 37

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 38

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 39

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 40

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 41

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 42

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 43

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 44

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 45

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 46

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 47

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 48

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 49

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 50

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 51

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 52

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 53

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 54

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 55

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 56

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 57

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 58

Riyadh, Saudi Arabia

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Boehringer Ingelheim Investigational Site 59

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 60

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 61

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 62

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 63

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 64

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 65

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 66

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 67

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 68

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 69

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 70

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 71

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 72

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 73

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 74

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 75

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 76

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 77

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 78

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 79

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 80

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 81

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 82

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 83

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 84

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 85

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 86

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 87

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 88

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 89

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 90

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 91

Western Region, Saudi Arabia

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Boehringer Ingelheim Investigational Site 113

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 114

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 115

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 116

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 117

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 118

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 119

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 120

Abu Dhabi, United Arab Emirates

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Boehringer Ingelheim Investigational Site 102

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 103

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 104

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 105

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 106

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 107

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 108

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 109

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 110

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 111

Dubai, United Arab Emirates

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Boehringer Ingelheim Investigational Site 112

Sharjah city, United Arab Emirates

Location

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

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2010
• Last Updated: April 10, 2014
• Results First Posted: July 2, 2012

Record last verified: 2014-03

Locations

SA (71); EG (30); AE (19)