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

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ClinicalTrials.gov Identifier: NCT01108796
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : December 30, 2011
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date March 11, 2010
First Posted Date April 22, 2010
Results First Submitted Date September 1, 2011
Results First Posted Date December 30, 2011
Last Update Posted Date April 10, 2014
Study Start Date September 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2011)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: April 21, 2010)
- Changes in mean blood pressure (systolic and diastolic) after treatment, compared to baseline [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT01108796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 28, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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'
Original Secondary Outcome Measures
 (submitted: April 21, 2010)
- Changes in laboratory parameters, if available, compared to baseline [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
Official Title 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 Observational
Study Design 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 Hypertension
Intervention Not Provided
Study Groups/Cohorts 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 Completed
Actual Enrollment
 (submitted: April 21, 2010)
1856
Original Actual Enrollment Same as current
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility 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).

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01108796
Other Study ID Numbers 502.579
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date February 2014