Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters

This study has been completed.

Study NCT00615108 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on January 31, 2008. Last Updated on February 11, 2010 History of Changes

Results First Received: December 16, 2009

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
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Hypertension Patients	Telmisartan 40mg or 80 mg

Participant Flow: Overall Study

	Hypertension Patients
STARTED	3148
COMPLETED	2641
NOT COMPLETED	507
Adverse Event	122
unknown	370
Lost to Follow-up	15

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Hypertension Patients	Telmisartan 40mg or 80 mg

Baseline Measures

	Hypertension Patients
Number of Participants [units: participants]	3148
Age [units: Years] Mean ± Standard Deviation	61.04 ± 12.36
Gender [units: participants]
Female	1623
Male	1525

Outcome Measures

1. Primary:

Percentage of Patients Achieving Blood Pressure (BP) Control [ Time Frame: 01-Dec-2006 to 31-Dec-2008 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

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:

	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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00615108 History of Changes
Other Study ID Numbers:	502.519
Study First Received:	January 31, 2008
Results First Received:	December 16, 2009
Last Updated:	February 11, 2010
Health Authority:	Taiwan: Department of Health Taiwan