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

March 11, 2010
February 28, 2014
September 2008
September 2009   (final data collection date for primary outcome measure)
  • 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
- Changes in mean blood pressure (systolic and diastolic) after treatment, compared to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01108796 on ClinicalTrials.gov Archive Site
  • 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'
- Changes in laboratory parameters, if available, compared to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with hypertension

Hypertension
Not Provided
Patients at cardiovascular risk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1856
September 2009
September 2009   (final data collection date for primary outcome measure)

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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT01108796
502.579
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

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