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J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00659581
First received: April 11, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: December 16, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension
Intervention: Drug: Telmisartan

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping).

Reporting Groups
  Description
Telmisartan No text entered.

Participant Flow:   Overall Study
    Telmisartan  
STARTED     20443  
COMPLETED     12412  
NOT COMPLETED     8031  
Adverse Event                 1006  
Lack of Efficacy                 1183  
Withdrawal by Subject                 5842  



  Baseline Characteristics
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Reporting Groups
  Description
Telmisartan No text entered.

Baseline Measures
    Telmisartan  
Number of Participants  
[units: participants]
 		  20443  
Age  
[units: years old]
Mean ± Standard Deviation 		  64.6  ± 12.0  
Gender  
[units: participants]
 		 
Female     10278  
Male     10165  



  Outcome Measures
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1.  Primary:   Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events   [ Time Frame: 3 years after initiation of treatment ]
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2.  Primary:   Change From Baseline in Systolic Blood Pressure at 6 Months   [ Time Frame: initiation and 6 months ]
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3.  Primary:   Change From Baseline in Diastolic Blood Pressure at 6 Months   [ Time Frame: initiation and 6 months ]
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4.  Primary:   Change From Baseline in Systolic Blood Pressure at 12 Months   [ Time Frame: initiation and 12 months ]
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5.  Primary:   Change From Baseline in Diastolic Blood Pressure at 12 Months   [ Time Frame: initiation and 12 months ]
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6.  Primary:   Change From Baseline in Systolic Blood Pressure at 24 Months   [ Time Frame: initiation and 24 months ]
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7.  Primary:   Change From Baseline in Diastolic Blood Pressure at 24 Months   [ Time Frame: initiation and 24 months ]
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8.  Primary:   Change From Baseline in Systolic Blood Pressure at 36 Months   [ Time Frame: initiation and 36 months ]
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9.  Primary:   Change From Baseline in Diastolic Blood Pressure at 36 Months   [ Time Frame: initiation and 36 months ]
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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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
This study is prospective observational study with no limitation of other antihypertensive treatment in compliance with Japanese Pharmaceutical Affairs Law (JPAL) and Good Post-marketing Study Practice (GPSP).  


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: NCT00659581     History of Changes
Other Study ID Numbers: 502.511
Study First Received: April 11, 2008
Results First Received: December 16, 2011
Last Updated: May 18, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare