Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension - Study Results

Study Type:	Observational
Study Design:	Prospective
Condition:	Hypertension

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Hypertensive Patients With Micardis Plus for the First Time	In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 6,606/ The number of patients for efficacy assessment: 6,120.

Participant Flow: Overall Study

	Hypertensive Patients With Micardis Plus for the First Time
STARTED	6901
COMPLETED	6120
NOT COMPLETED	781
Micardis+ before the date of contract	201
duplicated subjects	68
no start date of the treatment	20
Micardis Plus before diagnosed date	6
no blood pressure recorded	226
unknown measuring date of BP	118
unable to evaluate	104
no recorded efficacy date	34
inconsistent BP measuring date	4

Baseline Characteristics

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Reporting Groups

	Description
Hypertensive Patients With Micardis Plus for the First Time	In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 6,606/ The number of patients for efficacy assessment: 6,120.

Baseline Measures

	Hypertensive Patients With Micardis Plus for the First Time
Number of Participants [units: participants]	6606
Age [units: years] Mean ± Standard Deviation	59 ± 12
Gender^[1] [units: participants]
Female	3506
Male	3080

[1]	In PMS, there are totally three figures. The number of enrolled patients: 6901/ The number of patients for safety assessment: 6606/ The number of patients for efficacy assessment: 6120.

Outcome Measures

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1. Primary:

Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 [ Baseline and 2 weeks ]

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2. Primary:

Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 [ Baseline and 2 weeks ]

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Measure Type	Primary
Measure Title	Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
Measure Description	No text entered.
Time Frame	Baseline and 2 weeks
Safety Issue

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.
This analysis is efficacy analysis and the number of patients for efficacy assessment is 6120.

Reporting Groups

	Description
Hypertensive Patients With Micardis Plus for the First Time	In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 6,606/ The number of patients for efficacy assessment: 6,120.

Measured Values

	Hypertensive Patients With Micardis Plus for the First Time
Number of Participants Analyzed [units: participants]	6120
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 [units: mmHg] Mean ± Standard Deviation	-13 ± 10

Statistical Analysis 1 for Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2

Groups ^[1]	Hypertensive Patients With Micardis Plus for the First Time
Method ^[2]	t-test, 2 sided
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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 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 ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	502.475
Study First Received:	April 10, 2008
Results First Received:	July 29, 2009
Last Updated:	October 22, 2009
ClinicalTrials.gov Identifier:	NCT00659607 History of Changes
Health Authority:	Korea, Republic of: Korea Food and Drug Administration