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NCT00936208 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00936208
Other study ID # 502.584
Secondary ID
Status Completed
Phase N/A
First received July 8, 2009
Last updated March 12, 2014
Start date May 2009

Study information
Verified date March 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health and PopulationSaudi Arabia: Ministry of HealthUnited Arab Emirates: General Auth for Health Services Abu Dhabi
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 3184
Est. completion date
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
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 16 Alexandria West
Egypt Boehringer Ingelheim Investigational Site 17 Alexandria West
Egypt Boehringer Ingelheim Investigational Site 29 Assiut
Egypt Boehringer Ingelheim Investigational Site 1 Cairo
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 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
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 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
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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Egypt,  Saudi Arabia,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary Framingham Score at Week 24 The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). Week 24 No
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). Baseline and Week 24 No
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). Week 24 No
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). Baseline and Week 24 No
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 Baseline and Week 24 No
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