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Completed

NCT Number: NCT01108796

Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions.

The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control.

In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.

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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 34, ?adca, Slovenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients)
  • Patients with hypertension under treatment with one or more antihypertensive drug

Exclusion criteria

Patients are excluded according to the summary of product characteristics (SmPC).

Treatment and study plan

Primary outcomes

  1. Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool

  2. Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool

Secondary outcomes

  1. Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  2. Changes in Laboratory Parameters:High Density Lipoprotein (HDL)

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  3. Changes in Laboratory Parameters: Triglycerides

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  4. Changes in Laboratory Parameters: Blood Glucose

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  5. Assessment of Metabolic Effect

    Time frame: 24 weeks (Visit 1 to Visit 3)

    Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2010
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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