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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01108796
First received: March 11, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool

  • Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool


Secondary Outcome Measures:
  • Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  • Changes in Laboratory Parameters:High Density Lipoprotein (HDL) [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  • Changes in Laboratory Parameters: Triglycerides [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

  • Changes in Laboratory Parameters: Blood Glucose [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    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

  • Assessment of Metabolic Effect [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
    Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'


Enrollment: 1856
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients at cardiovascular risk

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with hypertension

Criteria

Inclusion criteria:

  1. 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)
  2. Patients with hypertension under treatment with one or more antihypertensive drug

Exclusion criteria:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108796

  Show 182 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
ClinicalTrials.gov Identifier: NCT01108796     History of Changes
Other Study ID Numbers: 502.579
Study First Received: March 11, 2010
Results First Received: September 1, 2011
Last Updated: February 28, 2014
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Telmisartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014