Telmisartan Tab Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00890084

First received: April 28, 2009

Last updated: May 21, 2012

Last verified: May 2012

History of Changes

Results First Received: December 30, 2011

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Hypertension
Intervention:	Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

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
April 1st 2009 to January 1st 2010 recruited in 90.5% General Practitioners (GP's) and 9.5% Specialists (Sp's)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
45 patients excluded for inclusion/exclusion criteria

Reporting Groups

	Description
Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)	No text entered.

Participant Flow: Overall Study

	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
STARTED	2913
COMPLETED	2771
NOT COMPLETED	142
Adverse Event	16
Lost to Follow-up	126

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)	No text entered.

Baseline Measures

	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Number of Participants [units: participants]	2913
Age, Customized [units: years] Mean ± Standard Deviation	64.4 ± 12.6
Gender, Customized [units: percentage of participants]
Female	48.8
Male	51.2
Systolic and diastolic blood pressure [units: mm Hg] Mean ± Standard Deviation
Systolic Blood Pressure	156.1 ± 12.9
Diastolic Blood Pressure	91.9 ± 8.64

Outcome Measures

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1. Primary:

Percentage of Patients With Blood Pressure < 140/90 mm Hg [ Time Frame: 12 weeks ]

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2. Secondary:

Percentage of Patients With Blood Pressure < 130/80 mm Hg [ Time Frame: 12 weeks ]

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3. Secondary:

Absolute Blood Pressure Decrease [ Time Frame: baseline and 12 weeks ]

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4. Secondary:

Change in Concomitant Antihypertensive Drugs Given at Study Entry [ Time Frame: baseline and 12 weeks ]

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5. Secondary:

Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg [ Time Frame: 12 weeks ]

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6. Secondary:

Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 [ Time Frame: 12 weeks ]

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Serious Adverse Events

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Time Frame	12 weeks
Additional Description	solicited reporting

Reporting Groups

	Description
Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)	No text entered.

Serious Adverse Events

	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Total, serious adverse events
# participants affected / at risk	3/2771 (0.11%)
Gastrointestinal disorders
Umbilical hernia ^{† 1}
# participants affected / at risk	1/2771 (0.04%)
Surgical and medical procedures
Alcohol detoxification ^{† 1}
# participants affected / at risk	1/2771 (0.04%)
Vascular disorders
cerebral hemorrhage, fatal ^{† 1}
# participants affected / at risk	1/2771 (0.04%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 13.1

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: Other - 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:	NCT00890084 History of Changes
Other Study ID Numbers:	502.581
Study First Received:	April 28, 2009
Results First Received:	December 30, 2011
Last Updated:	May 21, 2012
Health Authority:	Belgium: Federal Agency for Medicinal and Health Products

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