Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00613314

First received: January 31, 2008

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: February 8, 2010

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Hypertension Metabolic Syndrome X

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 protocol specified that the study will consist of 16,000 subjects. However, there are only 15, 268 case report froms (CRFs) submitted

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Telmisartan (Micardis)	No text entered.

Participant Flow: Overall Study

	Telmisartan (Micardis)
STARTED	15268
COMPLETED	15113
NOT COMPLETED	155
Adverse Event	5
Protocol Violation	14
Lost to Follow-up	46
Unknown	90

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan (Micardis)	No text entered.

Baseline Measures

	Telmisartan (Micardis)
Number of Participants [units: participants]	15268
Age [units: Years] Mean ± Standard Deviation	59 ± 9.9
Gender ^[1] [units: Number of participants]
Female	8253
Male	5876

[1]	The figure was based on the ITT (intention to treat) population which was reported in the PMS report. The total ITT population is 14, 161. There are 32 subjects with missing gender information

Outcome Measures

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1. Primary:

Change in Systolic Blood Pressure (SBP) From Baseline [ Time Frame: Baseline SBP up to 60 days ]

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2. Primary:

Change in Diastolic Blood Pressure (DBP) From Baseline [ Time Frame: Baseline DBP up to 60 days ]

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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
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00613314 History of Changes
Other Study ID Numbers:	502.532
Study First Received:	January 31, 2008
Results First Received:	February 8, 2010
Last Updated:	May 18, 2012
Health Authority:	Philippines: Department of Health Bureau of Food and Drugs

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