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

  Show 120 Study Locations
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
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014