PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
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ClinicalTrials.gov Identifier: NCT00936208 |
Recruitment Status
:
Completed
First Posted
: July 9, 2009
Results First Posted
: July 2, 2012
Last Update Posted
: April 10, 2014
|
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Condition or disease |
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Hypertension |
Study Type : | Observational |
Actual Enrollment : | 3184 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | To Evaluate the Safety, Efficacy, and Protection of Micardis 80 mg/Micardis Plus 80/12.5 mg From Cardiovascular Risks in a 24 Weeks Observational Study in Patients With Essential Hypertension Who Have at Least One Other Known Cardio-vascular Risk Factor |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | November 2010 |

Group/Cohort |
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Essential hypertensive men and women |
- Change in Diastolic Blood Pressure From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]The change from baseline reflects the week 24 value minus the baseline value.
- Change in Systolic Blood Pressure From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]The change from baseline reflects the week 24 value minus the baseline value.
- Framingham Score at Week 24 [ Time Frame: Week 24 ]The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
- Change in the Framingham Score From Baseline at Week 24 [ Time Frame: Baseline and 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).
- International Renal Interest Society (IRIS) II Score at Week 24 [ Time Frame: 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).
- Change in the IRIS II Score From Baseline at Week 24 [ Time Frame: Baseline and 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).
- Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results) [ Time Frame: Baseline and Week 24 ]The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- 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
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936208

Egypt | |
Boehringer Ingelheim Investigational Site 16 | |
Alexandria West, Egypt | |
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Alexandria West, Egypt | |
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Alexandria, Egypt | |
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Alexandria, Egypt | |
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Alexandria, Egypt | |
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Alexandria, Egypt | |
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Assiut, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Cairo, Egypt | |
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Domiat, Egypt | |
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El Garbia, Egypt | |
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El Minia, Egypt | |
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El Minia, Egypt | |
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Fakous - El Sharkia, Egypt | |
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Fayoum, Egypt | |
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Kalioubya, Egypt | |
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Mansoura - El Dakahlia, Egypt | |
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Menofia, Egypt | |
Boehringer Ingelheim Investigational Site 24 | |
Poert said, Egypt | |
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Zagazig - El Sharkia, Egypt | |
Saudi Arabia | |
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Eastern Region, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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Riyadh, Saudi Arabia | |
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United Arab Emirates | |
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Abu Dhabi, United Arab Emirates | |
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Abu Dhabi, United Arab Emirates | |
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Abu Dhabi, United Arab Emirates | |
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Abu Dhabi, United Arab Emirates | |
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Abu Dhabi, United Arab Emirates | |
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Dubai, United Arab Emirates | |
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Dubai, United Arab Emirates | |
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Dubai, United Arab Emirates | |
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Sharjah, United Arab Emirates |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00936208 History of Changes |
Other Study ID Numbers: |
502.584 |
First Posted: | July 9, 2009 Key Record Dates |
Results First Posted: | July 2, 2012 |
Last Update Posted: | April 10, 2014 |
Last Verified: | March 2014 |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Telmisartan |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |