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
Results First Received: September 1, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hypertension

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The aim of the study is to investigate the effect of the Lifestyle education tool (Tool/No Tool) for weight reduction on blood pressure control during a six-month treatment with Micardis® / MicardisPlus®. Patients were designated to participate or not participate in a Lifestyle education tool by the investigator under general practice conditions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1856 were entered into this trial and 1841 were analysed. For 15 patients case report forms were not available or not usable for analysis

Reporting Groups
  Description
Micardis® (Telmisartan) These patients in addition received Tool or No Tool treatment
MicardisPlus® (Telmisartan Hydrochlorothiazide) These patients in addition received Tool or No Tool treatment

Participant Flow:   Overall Study
    Micardis® (Telmisartan)     MicardisPlus® (Telmisartan Hydrochlorothiazide)  
STARTED     774     1067  
COMPLETED     767     1060  
NOT COMPLETED     7     7  
Adverse Event                 0                 1  
Lost to Follow-up                 7                 6  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Micardis® (Telmisartan) Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
MicardisPlus® (Telmisartan Hydrochlorothiazide) No text entered.
Tool (With Lifestyle Education Tool on Weight Reduction) No text entered.
No Tool (Without Lifestyle Education Tool on Weight Reduction) No text entered.
Total Total of all reporting groups

Baseline Measures
    Micardis® (Telmisartan)     MicardisPlus® (Telmisartan Hydrochlorothiazide)     Tool (With Lifestyle Education Tool on Weight Reduction)     No Tool (Without Lifestyle Education Tool on Weight Reduction)     Total  
Number of Participants  
[units: participants]
  774     1067     1187     654     3682  
Age [1]
[units: Years]
Mean ± Standard Deviation
  NA  ± NA [2]   NA  ± NA [2]   61.14  ± 10.09     61.94  ± 11.01     61.43  ± 10.43  
Gender, Customized [1]
[units: Participants]
         
Female, Tool/No Tool     0     0     679     390     1069  
Male, Tool/No Tool     0     0     507     264     771  
Female, Micardis®/MicardisPlus®     445     624     0     0     1069  
Male, Micardis®/MicardisPlus®     328     443     0     0     771  
[1] Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
[2] Mean and Standard Deviation numbers of patients' age per Micardis®/Micardis Plus® arms not available in the statistical analysis report



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

2.  Primary:   Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

3.  Secondary:   Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

4.  Secondary:   Changes in Laboratory Parameters:High Density Lipoprotein (HDL)   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

5.  Secondary:   Changes in Laboratory Parameters: Triglycerides   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

6.  Secondary:   Changes in Laboratory Parameters: Blood Glucose   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

7.  Secondary:   Assessment of Metabolic Effect   [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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