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PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936208
First Posted: July 9, 2009
Last Update Posted: April 10, 2014
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.
Information provided by:
Boehringer Ingelheim
Results First Submitted: April 19, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hypertension

  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
3184 patients were enrolled but treatment was unknown in 89 patients. Therefore, 3095 patients were analysed.

Reporting Groups
  Description
Micardis 80mg One tablet of Micardis 80mg per day
Micardis Plus 80mg / 12.5mg One tablet of Micardis Plus 80 / 12.5mg per day

Participant Flow:   Overall Study
    Micardis 80mg   Micardis Plus 80mg / 12.5mg
STARTED   1499   1596 
COMPLETED   1462   1574 
NOT COMPLETED   37   22 
Protocol Violation                37                22 



  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.
No text entered.

Reporting Groups
  Description
Micardis 80mg One tablet of Micardis 80mg per day
Micardis Plus 80mg / 12.5mg One tablet of Micardis Plus 80 / 12.5mg per day
Total Total of all reporting groups

Baseline Measures
   Micardis 80mg   Micardis Plus 80mg / 12.5mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 1499   1596   3095 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 49.8  (10.4)   53.1  (9.8)   51.5  (10.2) 
[1] Age was given for 1457 patients in the Micardis 80mg group and for 1569 patients in the Micardis Plus 80/12.5mg group.
Gender [1] 
[Units: Participants]
     
Female   500   434   934 
Male   931   1113   2044 
[1] Gender was given for 1431 patients in the Micardis 80mg group and for 1547 patients in the Micardis Plus 80/12.5mg group.
Framingham score at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 15.7  (12.3)   20.6  (12.5)   18.6  (12.6) 
[1] The baseline Framingham score was given for 1349 patients in the Micardis 80mg group and for 1482 patients in the Micardis Plus 80/12.5mg group. The score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
International Renal Interest Society (IRIS) II score at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 35.8  (33.8)   37.1  (32.2)   36.1  (32.9) 
[1] The baseline IRIS II score was given for 1122 patients in the Micardis 80mg group and for 1314 patients in the Micardis Plus 80/12.5mg group. The score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).


  Outcome Measures
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1.  Primary:   Change in Diastolic Blood Pressure From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Change in Systolic Blood Pressure From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Framingham Score at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Change in the Framingham Score From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   International Renal Interest Society (IRIS) II Score at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   Change in the IRIS II Score From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)   [ Time Frame: Baseline and Week 24 ]


  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
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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:
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 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.


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



Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00936208     History of Changes
Other Study ID Numbers: 502.584
First Submitted: July 8, 2009
First Posted: July 9, 2009
Results First Submitted: April 19, 2012
Results First Posted: July 2, 2012
Last Update Posted: April 10, 2014