Trial Outcomes & Findings for PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg (NCT NCT00936208)
NCT ID: NCT00936208
Last Updated: 2014-04-10
Results Overview
The change from baseline reflects the week 24 value minus the baseline value.
COMPLETED
3184 participants
Baseline and Week 24
2014-04-10
Participant Flow
3184 patients were enrolled but treatment was unknown in 89 patients. Therefore, 3095 patients were analysed.
Participant milestones
| Measure |
Micardis 80mg
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Overall Study
STARTED
|
1499
|
1596
|
|
Overall Study
COMPLETED
|
1462
|
1574
|
|
Overall Study
NOT COMPLETED
|
37
|
22
|
Reasons for withdrawal
| Measure |
Micardis 80mg
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Overall Study
Protocol Violation
|
37
|
22
|
Baseline Characteristics
PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
Baseline characteristics by cohort
| Measure |
Micardis 80mg
n=1499 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1596 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
Total
n=3095 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
53.1 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
51.5 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Gender
Female
|
500 participants
n=93 Participants
|
434 participants
n=4 Participants
|
934 participants
n=27 Participants
|
|
Gender
Male
|
931 participants
n=93 Participants
|
1113 participants
n=4 Participants
|
2044 participants
n=27 Participants
|
|
Framingham score at baseline
|
15.7 Units on a scale
STANDARD_DEVIATION 12.3 • n=93 Participants
|
20.6 Units on a scale
STANDARD_DEVIATION 12.5 • n=4 Participants
|
18.6 Units on a scale
STANDARD_DEVIATION 12.6 • n=27 Participants
|
|
International Renal Interest Society (IRIS) II score at baseline
|
35.8 Units on a scale
STANDARD_DEVIATION 33.8 • n=93 Participants
|
37.1 Units on a scale
STANDARD_DEVIATION 32.2 • n=4 Participants
|
36.1 Units on a scale
STANDARD_DEVIATION 32.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24
The change from baseline reflects the week 24 value minus the baseline value.
Outcome measures
| Measure |
Micardis 80mg
n=1462 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1574 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline at Week 24
|
-15.3 mmHg
Standard Deviation 8.6
|
-18.3 mmHg
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24
The change from baseline reflects the week 24 value minus the baseline value.
Outcome measures
| Measure |
Micardis 80mg
n=1462 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1574 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline at Week 24
|
-26.6 mmHg
Standard Deviation 13.7
|
-32.8 mmHg
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Week 24Population: Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24
The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
Outcome measures
| Measure |
Micardis 80mg
n=1349 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1482 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Framingham Score at Week 24
|
10.6 Units on a scale
Standard Deviation 8.4
|
14.2 Units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24
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).
Outcome measures
| Measure |
Micardis 80mg
n=1349 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1482 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Change in the Framingham Score From Baseline at Week 24
|
-5.2 Units on a scale
Standard Deviation 8.7
|
-6.3 Units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Week 24Population: Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24
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).
Outcome measures
| Measure |
Micardis 80mg
n=1122 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1314 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
International Renal Interest Society (IRIS) II Score at Week 24
|
30.9 Units on a scale
Standard Deviation 30.3
|
31.7 Units on a scale
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24
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).
Outcome measures
| Measure |
Micardis 80mg
n=1122 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1314 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Change in the IRIS II Score From Baseline at Week 24
|
-5.8 Units on a scale
Standard Deviation 13.9
|
-7.0 Units on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24
The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24
Outcome measures
| Measure |
Micardis 80mg
n=1390 Participants
One tablet of Micardis 80mg per day
|
Micardis Plus 80mg / 12.5mg
n=1514 Participants
One tablet of Micardis Plus 80 / 12.5mg per day
|
|---|---|---|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 0 to end-of-study 0
|
821 participants
|
668 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 0 to end-of-study 30
|
21 participants
|
26 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 0 to end-of-study 100
|
1 participants
|
9 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 0 to end-of-study 500
|
0 participants
|
0 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 30 to end-of-study 0
|
220 participants
|
264 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 30 to end-of-study 30
|
114 participants
|
141 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 30 to end-of-study 100
|
4 participants
|
0 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 30 to end-of-study 500
|
0 participants
|
0 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 100 to end-of-study 0
|
65 participants
|
90 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 100 to end-of-study 30
|
91 participants
|
197 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 100 to end-of-study 100
|
11 participants
|
38 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 100 to end-of-study 500
|
0 participants
|
0 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 500 to end-of-study 0
|
3 participants
|
12 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 500 to end-of-study 30
|
9 participants
|
25 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 500 to end-of-study 100
|
21 participants
|
35 participants
|
|
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Shift from baseline 500 to end-of-study 500
|
9 participants
|
9 participants
|
Adverse Events
Micardis 80mg
Micardis Plus 80mg / 12.5mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER