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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00936208
First received: July 8, 2009
Last updated: May 23, 2012
Last verified: May 2012
History of Changes

July 8, 2009
May 23, 2012
May 2009
November 2010   (final data collection date for primary outcome measure)
  • 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.
Change from baseline in systolic and diastolic blood pressure on week 24 after treatment with either Telmisartan 80 mg (Micardis) or with Telmisartan Plus 80/12.5 mg (Micardis Plus). Incidence of serious adverse events reported during 24 weeks [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00936208 on ClinicalTrials.gov Archive Site
  • 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
Screen enrolled patients for the prevalence of microalbuminuria at baseline and 24 weeks visits Calculate cardiovascular risk factor with the Risk calculator using Framingham score and IRIS II [ Time Frame: 24 weeks ]
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PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
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

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates
Hypertension
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Essential hypertensive men and women
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3184
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November 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt,   Saudi Arabia,   United Arab Emirates
 
NCT00936208
502.584
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP