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

Results First Received: September 1, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Hypertension

Participant Flow

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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

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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 automaticly. 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 automaticly. 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

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

Changes in Laboratory Parameters: Tryglicerides [ Time Frame: 24 weeks (Visit 1 to Visit 3) ]

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6. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract

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.

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 Pharmaceuticals
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 13, 2013
Health Authority:	Slovakia: State Institute for Drug Control

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