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 Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01108796

First received: March 11, 2010

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2010

Last Updated Date

February 13, 2013

Start Date ^ICMJE

September 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

- Changes in mean blood pressure (systolic and diastolic) after treatment, compared to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01108796 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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: Tryglicerides [ Time Frame: 24 weeks (Visit 1 to Visit 3) ] [ Designated as safety issue: No ]
Changes in the trygliceride 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

Original Secondary Outcome Measures ^ICMJE

- Changes in laboratory parameters, if available, compared to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with hypertension

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients at cardiovascular risk

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1856

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Slovenia

Administrative Information

NCT Number ^ICMJE

NCT01108796

Other Study ID Numbers ^ICMJE

502.579

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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