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Completed

NCT Number: NCT00936208

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

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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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 28, Al Fayyum, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
First posted
Jul 9, 2009
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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