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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00936208
First received: July 8, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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
Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in Diastolic Blood Pressure From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24


Enrollment: 3184
Study Start Date: May 2009
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Essential hypertensive men and women

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936208

  Hide Study Locations
Locations
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 3
Cairo, Egypt
Boehringer Ingelheim Investigational Site 9
Cairo, Egypt
Boehringer Ingelheim Investigational Site 10
Cairo, Egypt
Boehringer Ingelheim Investigational Site 11
Cairo, Egypt
Boehringer Ingelheim Investigational Site 2
Cairo, Egypt
Boehringer Ingelheim Investigational Site 4
Cairo, Egypt
Boehringer Ingelheim Investigational Site 5
Cairo, Egypt
Boehringer Ingelheim Investigational Site 8
Cairo, Egypt
Boehringer Ingelheim Investigational Site 6
Cairo, Egypt
Boehringer Ingelheim Investigational Site 7
Cairo, Egypt
Boehringer Ingelheim Investigational Site 1
Cairo, Egypt
Boehringer Ingelheim Investigational Site 12
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 93
Eastern Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 100
Eastern Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 99
Eastern Region, Saudi Arabia
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Eastern Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 101
Eastern Region, Saudi Arabia
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Eastern Region, Saudi Arabia
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Eastern Region, Saudi Arabia
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Eastern Region, Saudi Arabia
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Eastern Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 92
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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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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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
Boehringer Ingelheim Investigational Site 34
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 51
Riyadh, 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
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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
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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
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Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 65
Western Region, Saudi Arabia
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Western Region, Saudi Arabia
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Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 68
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 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 67
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 66
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 82
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 64
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 63
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 62
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 60
Western Region, Saudi Arabia
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Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 85
Western Region, Saudi Arabia
Boehringer Ingelheim Investigational Site 61
Western Region, Saudi Arabia
United Arab Emirates
Boehringer Ingelheim Investigational Site 118
Abu Dhabi, United Arab Emirates
Boehringer Ingelheim Investigational Site 120
Abu Dhabi, United Arab Emirates
Boehringer Ingelheim Investigational Site 119
Abu Dhabi, United Arab Emirates
Boehringer Ingelheim Investigational Site 113
Abu Dhabi, United Arab Emirates
Boehringer Ingelheim Investigational Site 117
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 114
Abu Dhabi, United Arab Emirates
Boehringer Ingelheim Investigational Site 102
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 103
Dubai, United Arab Emirates
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Dubai, United Arab Emirates
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Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 106
Dubai, United Arab Emirates
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Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 108
Dubai, United Arab Emirates
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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
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00936208     History of Changes
Other Study ID Numbers: 502.584
Study First Received: July 8, 2009
Results First Received: April 19, 2012
Last Updated: March 12, 2014
Health Authority: Egypt: Ministry of Health and Population
Saudi Arabia: Ministry of Health
United Arab Emirates: General Auth for Health Services Abu Dhabi

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014