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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01562613
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : July 30, 2014
Last Update Posted : August 12, 2014
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: 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
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
Hypertensive Patients All eligible hypertensive patients treated with eprosartan

Participant Flow:   Overall Study
    Hypertensive Patients
STARTED   533 
Lost to Follow-up                2 
Withdrawal by Subject                2 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
Hypertensive Patients All eligible hypertensive patients treated with eprosartan

Baseline Measures
   Hypertensive Patients 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 63.4  (11.9) 
[Units: Participants]
Female   276 
Male   257 
Region of Enrollment 
[Units: Participants]
Greece   533 

  Outcome Measures

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

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

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

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01562613     History of Changes
Other Study ID Numbers: P13-165
First Submitted: March 16, 2012
First Posted: March 26, 2012
Results First Submitted: March 27, 2014
Results First Posted: July 30, 2014
Last Update Posted: August 12, 2014