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

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ClinicalTrials.gov Identifier: NCT00936208
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : July 2, 2012
Last Update Posted : April 10, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hypertension
Enrollment 3184
Recruitment Details  
Pre-assignment Details 3184 patients were enrolled but treatment was unknown in 89 patients. Therefore, 3095 patients were analysed.
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description One tablet of Micardis 80mg per day One tablet of Micardis Plus 80 / 12.5mg per day
Period Title: Overall Study
Started 1499 1596
Completed 1462 1574
Not Completed 37 22
Reason Not Completed
Protocol Violation             37             22
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg Total
Hide Arm/Group Description One tablet of Micardis 80mg per day One tablet of Micardis Plus 80 / 12.5mg per day Total of all reporting groups
Overall Number of Baseline Participants 1499 1596 3095
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1499 participants 1596 participants 3095 participants
49.8  (10.4) 53.1  (9.8) 51.5  (10.2)
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1499 participants 1596 participants 3095 participants
Female 500 434 934
Male 931 1113 2044
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1499 participants 1596 participants 3095 participants
15.7  (12.3) 20.6  (12.5) 18.6  (12.6)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1499 participants 1596 participants 3095 participants
35.8  (33.8) 37.1  (32.2) 36.1  (32.9)
[1]
Measure Description: 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).
1.Primary Outcome
Title Change in Diastolic Blood Pressure From Baseline at Week 24
Hide Description The change from baseline reflects the week 24 value minus the baseline value.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1462 1574
Mean (Standard Deviation)
Unit of Measure: mmHg
-15.3  (8.6) -18.3  (8.4)
2.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline at Week 24
Hide Description The change from baseline reflects the week 24 value minus the baseline value.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1462 1574
Mean (Standard Deviation)
Unit of Measure: mmHg
-26.6  (13.7) -32.8  (15.0)
3.Secondary Outcome
Title Framingham Score at Week 24
Hide Description The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1349 1482
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.6  (8.4) 14.2  (9.7)
4.Secondary Outcome
Title Change in the Framingham Score From Baseline at Week 24
Hide Description The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1349 1482
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.2  (8.7) -6.3  (8.4)
5.Secondary Outcome
Title International Renal Interest Society (IRIS) II Score at Week 24
Hide Description The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1122 1314
Mean (Standard Deviation)
Unit of Measure: Units on a scale
30.9  (30.3) 31.7  (28.8)
6.Secondary Outcome
Title Change in the IRIS II Score From Baseline at Week 24
Hide Description The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1122 1314
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.8  (13.9) -7.0  (14.7)
7.Secondary Outcome
Title Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Hide Description The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description:
One tablet of Micardis 80mg per day
One tablet of Micardis Plus 80 / 12.5mg per day
Overall Number of Participants Analyzed 1390 1514
Measure Type: Number
Unit of Measure: participants
Shift from baseline 0 to end-of-study 0 821 668
Shift from baseline 0 to end-of-study 30 21 26
Shift from baseline 0 to end-of-study 100 1 9
Shift from baseline 0 to end-of-study 500 0 0
Shift from baseline 30 to end-of-study 0 220 264
Shift from baseline 30 to end-of-study 30 114 141
Shift from baseline 30 to end-of-study 100 4 0
Shift from baseline 30 to end-of-study 500 0 0
Shift from baseline 100 to end-of-study 0 65 90
Shift from baseline 100 to end-of-study 30 91 197
Shift from baseline 100 to end-of-study 100 11 38
Shift from baseline 100 to end-of-study 500 0 0
Shift from baseline 500 to end-of-study 0 3 12
Shift from baseline 500 to end-of-study 30 9 25
Shift from baseline 500 to end-of-study 100 21 35
Shift from baseline 500 to end-of-study 500 9 9
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Micardis 80mg Micardis Plus 80mg / 12.5mg
Hide Arm/Group Description One tablet of Micardis 80mg per day One tablet of Micardis Plus 80 / 12.5mg per day
All-Cause Mortality
Micardis 80mg Micardis Plus 80mg / 12.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Micardis 80mg Micardis Plus 80mg / 12.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1499 (0.00%)   0/1596 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Micardis 80mg Micardis Plus 80mg / 12.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1499 (0.00%)   0/1596 (0.00%) 
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.
Other - 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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
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