A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01562613
First received: March 16, 2012
Last updated: July 29, 2014
Last verified: July 2014
Results First Received: March 27, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Hypertension
Stroke

  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
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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 All eligible hypertensive patients treated with eprosartan

Participant Flow:   Overall Study
    Hypertensive Patients  
STARTED     533  
COMPLETED     529  
NOT COMPLETED     4  
Lost to Follow-up                 2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Hypertensive Patients All eligible hypertensive patients treated with eprosartan

Baseline Measures
    Hypertensive Patients  
Number of Participants  
[units: participants]
  533  
Age  
[units: years]
Mean ± Standard Deviation
  63.4  ± 11.9  
Gender  
[units: participants]
 
Female     276  
Male     257  
Region of Enrollment  
[units: participants]
 
Greece     533  



  Outcome Measures
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1.  Primary:   The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.   [ Time Frame: Baseline up to 6 months ]

2.  Primary:   The Absolute Change in Systolic Blood Pressure From Baseline   [ Time Frame: Baseline up to 6 months ]

3.  Secondary:   Change in Framingham Stroke Risk Profile Scores of the Participating Patients   [ Time Frame: Baseline up to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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 important limitations apply. Missing data and drop-out rate was very low; but some factors required for patient CV (cardiovascular) risk classification were unknown and may have resulted in CV risk underestimation in a limited number of patients.


  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Taco Baardman
Organization: Abbott
e-mail: taco.baardman@abbott.com


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01562613     History of Changes
Other Study ID Numbers: P13-165
Study First Received: March 16, 2012
Results First Received: March 27, 2014
Last Updated: July 29, 2014
Health Authority: Greece: Ministry of Health and Welfare