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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential hypertensive men and women |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Framingham Score at Week 24 | The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). | Week 24 |
| Change in the Framingham Score From Baseline at Week 24 |
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Inclusion criteria:
Exclusion criteria:
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Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 28 | Al Fayyum | Egypt | ||||
| Boehringer Ingelheim Investigational Site 18 |
3184 patients were enrolled but treatment was unknown in 89 patients. Therefore, 3095 patients were analysed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micardis 80mg | One tablet of Micardis 80mg per day |
| FG001 | Micardis Plus 80mg / 12.5mg | One tablet of Micardis Plus 80 / 12.5mg per day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
| Baseline and Week 24 |
| International Renal Interest Society (IRIS) II Score at Week 24 | The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Week 24 |
| Change in the IRIS II Score From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Baseline and Week 24 |
| Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results) | The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24 | Baseline and Week 24 |
| Alexandria |
| Egypt |
| Boehringer Ingelheim Investigational Site 19 | Alexandria | Egypt |
| Boehringer Ingelheim Investigational Site 20 | Alexandria | Egypt |
| Boehringer Ingelheim Investigational Site 21 | Alexandria | Egypt |
| Boehringer Ingelheim Investigational Site 16 | Alexandria West | Egypt |
| Boehringer Ingelheim Investigational Site 17 | Alexandria West | Egypt |
| Boehringer Ingelheim Investigational Site 29 | Asyut | Egypt |
| Boehringer Ingelheim Investigational Site 10 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 11 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 12 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 1 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 2 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 3 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 4 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 5 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 6 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 7 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 8 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 9 | Cairo | Egypt |
| Boehringer Ingelheim Investigational Site 22 | Domiat | Egypt |
| Boehringer Ingelheim Investigational Site 23 | El Garbia | Egypt |
| Boehringer Ingelheim Investigational Site 25 | Fakous - El Sharkia | Egypt |
| Boehringer Ingelheim Investigational Site 13 | Kalioubya | Egypt |
| Boehringer Ingelheim Investigational Site 27 | Mansoura - El Dakahlia | Egypt |
| Boehringer Ingelheim Investigational Site 30 | Menofia | Egypt |
| Boehringer Ingelheim Investigational Site 14 | Minya | Egypt |
| Boehringer Ingelheim Investigational Site 15 | Minya | Egypt |
| Boehringer Ingelheim Investigational Site 24 | Poert Said | Egypt |
| Boehringer Ingelheim Investigational Site 26 | Zagazig - El Sharkia | Egypt |
| Boehringer Ingelheim Investigational Site 100 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 101 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 92 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 93 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 94 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 95 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 96 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 97 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 98 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 99 | Eastern Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 31 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 32 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 33 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 34 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 35 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 36 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 37 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 38 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 39 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 40 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 41 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 42 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 43 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 44 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 45 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 46 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 47 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 48 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 49 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 50 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 51 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 52 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 53 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 54 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 55 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 56 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 57 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 58 | Riyadh | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 59 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 60 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 61 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 62 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 63 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 64 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 65 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 66 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 67 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 68 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 69 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 70 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 71 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 72 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 73 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 74 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 75 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 76 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 77 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 78 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 79 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 80 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 81 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 82 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 83 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 84 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 85 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 86 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 87 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 88 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 89 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 90 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 91 | Western Region | Saudi Arabia |
| Boehringer Ingelheim Investigational Site 113 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 114 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 115 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 116 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 117 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 118 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 119 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 120 | Abu Dhabi | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 102 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 103 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 104 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 105 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 106 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 107 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 108 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 109 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 110 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 111 | Dubai | United Arab Emirates |
| Boehringer Ingelheim Investigational Site 112 | Sharjah city | United Arab Emirates |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Micardis 80mg | One tablet of Micardis 80mg per day |
| BG001 | Micardis Plus 80mg / 12.5mg | One tablet of Micardis Plus 80 / 12.5mg per day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was given for 1457 patients in the Micardis 80mg group and for 1569 patients in the Micardis Plus 80/12.5mg group. | Mean | Standard Deviation | years |
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| Gender | Gender was given for 1431 patients in the Micardis 80mg group and for 1547 patients in the Micardis Plus 80/12.5mg group. | Number | participants |
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| Framingham score at baseline | The baseline Framingham score was given for 1349 patients in the Micardis 80mg group and for 1482 patients in the Micardis Plus 80/12.5mg group. The score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||
| International Renal Interest Society (IRIS) II score at baseline | The baseline IRIS II score was given for 1122 patients in the Micardis 80mg group and for 1314 patients in the Micardis Plus 80/12.5mg group. The score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Mean | Standard Deviation | Units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Diastolic Blood Pressure From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. | Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24 | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 24 |
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| Primary | Change in Systolic Blood Pressure From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. | Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24 | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 24 |
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| Secondary | Framingham Score at Week 24 | The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). | Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24 | Posted | Mean | Standard Deviation | Units on a scale | Week 24 |
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| Secondary | Change in the Framingham Score From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). | Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24 | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 |
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| Secondary | International Renal Interest Society (IRIS) II Score at Week 24 | The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24 | Posted | Mean | Standard Deviation | Units on a scale | Week 24 |
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| Secondary | Change in the IRIS II Score From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24 | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 |
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| Secondary | Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results) | The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24 | Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24 | Posted | Number | participants | Baseline and Week 24 |
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24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micardis 80mg | One tablet of Micardis 80mg per day | 0 | 1,499 | 0 | 1,499 | ||
| EG001 | Micardis Plus 80mg / 12.5mg | One tablet of Micardis Plus 80 / 12.5mg per day | 0 | 1,596 | 0 | 1,596 |
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Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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