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Completed

NCT Number: NCT00904371

Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risks. Further on, the study will evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 2, Brežice, Slovenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
  • at least an additional cardiovascular risk factor

Exclusion criteria

  • hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market
  • pregnancy and lactation
  • diseases involving biliary obstruction
  • severe liver impairment

Treatment and study plan

Primary outcomes

  1. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline to 3rd visit (4-10 months)

  2. Change From Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline to 3rd visit (4-10 months)

  3. Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)

    Time frame: Baseline to 3rd visit (4-10 months)

    A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.

  4. Change From Baseline in Framingham CVD Risk Assessment Score

    Time frame: Baseline to 3rd visit (4-10 months)

    10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).

  5. Change From Baseline in Framingham Stroke Risk Assessment Score

    Time frame: Baseline to 3rd visit (4-10 months)

    The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).

  6. Change From Baseline in Risk Assessment According to ESH/ESC Guidelines

    Time frame: Baseline to 3rd visit (4-10 months)

    ESH is the European society of hypertension, and ESC is the European society of cardiology.

Secondary outcomes

  1. Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC

    Time frame: 3rd visit (4-10 months)

    ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients

  2. Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)

    Time frame: 3rd visit (4-10 months)

    Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.

  3. Change in Heart Rate From Baseline to Study End

    Time frame: Baseline to 3rd visit (4-10 months)

  4. Number of Patients With Adverse Events (AE)

    Time frame: 4-10 months

  5. Number of Participants Not Completing Study

    Time frame: 3rd visit (4-10 months)

    Number of participants discontinuing study early for given reason

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Important dates

Study start
2009
Primary completion
2011
First posted
May 19, 2009
Registry last updated
Aug 21, 2012

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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