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Completed

NCT Number: NCT01108809

Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk 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 risk scores. The study will also 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 1, Arad, Romania

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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 one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease

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, as prescribed in the SPC
  • pregnancy and lactation
  • diseases involving biliary obstruction
  • severe liver impairment
  • severe hypertension
  • malignant hypertension
  • secondary hypertension
  • patients age under 18 years

Treatment and study plan

Telmisartan or Telmisartan and Hydrochlorthiazide

Drug

Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg

Primary outcomes

  1. Change in Systolic Blood Pressure From Baseline to Study End

    Time frame: From baseline to visit 3 (6 months)

  2. Change in Diastolic Blood Pressure From Baseline to Study End

    Time frame: From baseline to visit 3 (6 months)

  3. Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End

    Time frame: From baseline to visit 3 (6 months)

    A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  4. Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End

    Time frame: From baseline to visit 3 (6 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). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  5. Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End

    Time frame: From baseline to visit 3 (6 months)

    ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

Secondary outcomes

  1. Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)

    Time frame: Visit 3 (6 months from baseline)

    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: 6 Months

  3. Change in Heart Rate From Baseline to Study End

    Time frame: From baseline to visit 3 (6 months)

  4. Number of Participants Not Completing Study

    Time frame: 3rd visit (6 months)

    Number of participants discontinuing study early for given reason

  5. Number of Patients With Adverse Events (AE)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 22, 2010
Registry last updated
Mar 28, 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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