PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00936208 |
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Recruitment Status
:
Completed
First Posted
: July 9, 2009
Results First Posted
: July 2, 2012
Last Update Posted
: April 10, 2014
|
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
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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
| Condition or disease |
|---|
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Telmisartan
U.S. FDA Resources
| Group/Cohort |
|---|
| Essential hypertensive men and women |
Primary Outcome Measures
:
- 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.
Secondary Outcome Measures
:
- 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
Information from the National Library of Medicine
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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 |
Study Population
Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates
Criteria
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.
Information from the National Library of Medicine
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
Hide Study Locations
Locations
| Egypt | |
| Boehringer Ingelheim Investigational Site 16 | |
| Alexandria West, Egypt | |
| Boehringer Ingelheim Investigational Site 17 | |
| Alexandria West, Egypt | |
| Boehringer Ingelheim Investigational Site 18 | |
| 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 29 | |
| Assiut, 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 14 | |
| El Minia, Egypt | |
| Boehringer Ingelheim Investigational Site 15 | |
| El Minia, Egypt | |
| Boehringer Ingelheim Investigational Site 25 | |
| Fakous - El Sharkia, Egypt | |
| Boehringer Ingelheim Investigational Site 28 | |
| Fayoum, 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 24 | |
| Poert said, Egypt | |
| Boehringer Ingelheim Investigational Site 26 | |
| Zagazig - El Sharkia, Egypt | |
| Saudi Arabia | |
| 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 | |
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| Eastern Region, Saudi Arabia | |
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| 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 | |
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| 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 | |
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| 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 | |
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| Western Region, Saudi Arabia | |
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| Western Region, Saudi Arabia | |
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| Western Region, Saudi Arabia | |
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| 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 | |
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| Western Region, Saudi Arabia | |
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| Western Region, Saudi Arabia | |
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| Western Region, Saudi Arabia | |
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| Western Region, Saudi Arabia | |
| Boehringer Ingelheim Investigational Site 91 | |
| Western Region, Saudi Arabia | |
| United Arab Emirates | |
| 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, United Arab Emirates | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| 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 |