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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00936208
• Collaborator: (none)
• Enrollment: 3,184
• Locations: 120
• Patients Per Site: 26.5

Study Details

Study Description

Brief Summary

PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients will have essential hypertension. In addition, the patients will have at least one other contributing risk factor for cardiovascular events. The study aims to evaluate the safety, efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in patients with essential hypertension

Condition or Disease	Intervention/Treatment	Phase
Hypertension

Study Design

• Study Type: Observational
• Actual Enrollment: 3184 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: To Evaluate the Safety, Efficacy, and Protection of Micardis 80 mg/Micardis Plus 80/12.5 mg From Cardiovascular Risks in a 24 Weeks Observational Study in Patients With Essential Hypertension Who Have at Least One Other Known Cardio-vascular Risk Factor
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Essential hypertensive men and women

Outcome Measures

Primary Outcome Measures

1. Change in Diastolic Blood Pressure From Baseline at Week 24 [Baseline and Week 24]

   The change from baseline reflects the week 24 value minus the baseline value.

2. Change in Systolic Blood Pressure From Baseline at Week 24 [Baseline and Week 24]

   The change from baseline reflects the week 24 value minus the baseline value.

Secondary Outcome Measures

1. Framingham Score at Week 24 [Week 24]

   The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).

2. Change in the Framingham Score From Baseline at Week 24 [Baseline and 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).

3. International Renal Interest Society (IRIS) II Score at Week 24 [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).

4. Change in the IRIS II Score From Baseline at Week 24 [Baseline and 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).

5. Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results) [Baseline and Week 24]

   The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Male or female

• Aged 20 to 80 years old.

• adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled

• Sitting blood pressure: systolic BP > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg)

• At least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as > 55 years (Males), > 65 years (Females), smoking, overweight or obese patients or a combination of above risk factors

• Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication

Exclusion criteria:

• Patients with contraindications to Telmisartan use (as per the Micardis® Tablets package insert).

• Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® .

• Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.

• Patients participating in any other clinical trial.

• Patients already on Micardis® alone or combination

• Pregnant females, or females breast feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boehringer Ingelheim Investigational Site 16	Alexandria West		Egypt
2	Boehringer Ingelheim Investigational Site 17	Alexandria West		Egypt
3	Boehringer Ingelheim Investigational Site 18	Alexandria		Egypt
4	Boehringer Ingelheim Investigational Site 19	Alexandria		Egypt
5	Boehringer Ingelheim Investigational Site 20	Alexandria		Egypt
6	Boehringer Ingelheim Investigational Site 21	Alexandria		Egypt
7	Boehringer Ingelheim Investigational Site 29	Assiut		Egypt
8	Boehringer Ingelheim Investigational Site 10	Cairo		Egypt
9	Boehringer Ingelheim Investigational Site 11	Cairo		Egypt
10	Boehringer Ingelheim Investigational Site 12	Cairo		Egypt
11	Boehringer Ingelheim Investigational Site 1	Cairo		Egypt
12	Boehringer Ingelheim Investigational Site 2	Cairo		Egypt
13	Boehringer Ingelheim Investigational Site 3	Cairo		Egypt
14	Boehringer Ingelheim Investigational Site 4	Cairo		Egypt
15	Boehringer Ingelheim Investigational Site 5	Cairo		Egypt
16	Boehringer Ingelheim Investigational Site 6	Cairo		Egypt
17	Boehringer Ingelheim Investigational Site 7	Cairo		Egypt
18	Boehringer Ingelheim Investigational Site 8	Cairo		Egypt
19	Boehringer Ingelheim Investigational Site 9	Cairo		Egypt
20	Boehringer Ingelheim Investigational Site 22	Domiat		Egypt
21	Boehringer Ingelheim Investigational Site 23	El Garbia		Egypt
22	Boehringer Ingelheim Investigational Site 14	El Minia		Egypt
23	Boehringer Ingelheim Investigational Site 15	El Minia		Egypt
24	Boehringer Ingelheim Investigational Site 25	Fakous - El Sharkia		Egypt
25	Boehringer Ingelheim Investigational Site 28	Fayoum		Egypt
26	Boehringer Ingelheim Investigational Site 13	Kalioubya		Egypt
27	Boehringer Ingelheim Investigational Site 27	Mansoura - El Dakahlia		Egypt
28	Boehringer Ingelheim Investigational Site 30	Menofia		Egypt
29	Boehringer Ingelheim Investigational Site 24	Poert said		Egypt
30	Boehringer Ingelheim Investigational Site 26	Zagazig - El Sharkia		Egypt
31	Boehringer Ingelheim Investigational Site 100	Eastern Region		Saudi Arabia
32	Boehringer Ingelheim Investigational Site 101	Eastern Region		Saudi Arabia
33	Boehringer Ingelheim Investigational Site 92	Eastern Region		Saudi Arabia
34	Boehringer Ingelheim Investigational Site 93	Eastern Region		Saudi Arabia
35	Boehringer Ingelheim Investigational Site 94	Eastern Region		Saudi Arabia
36	Boehringer Ingelheim Investigational Site 95	Eastern Region		Saudi Arabia
37	Boehringer Ingelheim Investigational Site 96	Eastern Region		Saudi Arabia
38	Boehringer Ingelheim Investigational Site 97	Eastern Region		Saudi Arabia
39	Boehringer Ingelheim Investigational Site 98	Eastern Region		Saudi Arabia
40	Boehringer Ingelheim Investigational Site 99	Eastern Region		Saudi Arabia
41	Boehringer Ingelheim Investigational Site 31	Riyadh		Saudi Arabia
42	Boehringer Ingelheim Investigational Site 32	Riyadh		Saudi Arabia
43	Boehringer Ingelheim Investigational Site 33	Riyadh		Saudi Arabia
44	Boehringer Ingelheim Investigational Site 34	Riyadh		Saudi Arabia
45	Boehringer Ingelheim Investigational Site 35	Riyadh		Saudi Arabia
46	Boehringer Ingelheim Investigational Site 36	Riyadh		Saudi Arabia
47	Boehringer Ingelheim Investigational Site 37	Riyadh		Saudi Arabia
48	Boehringer Ingelheim Investigational Site 38	Riyadh		Saudi Arabia
49	Boehringer Ingelheim Investigational Site 39	Riyadh		Saudi Arabia
50	Boehringer Ingelheim Investigational Site 40	Riyadh		Saudi Arabia
51	Boehringer Ingelheim Investigational Site 41	Riyadh		Saudi Arabia
52	Boehringer Ingelheim Investigational Site 42	Riyadh		Saudi Arabia
53	Boehringer Ingelheim Investigational Site 43	Riyadh		Saudi Arabia
54	Boehringer Ingelheim Investigational Site 44	Riyadh		Saudi Arabia
55	Boehringer Ingelheim Investigational Site 45	Riyadh		Saudi Arabia
56	Boehringer Ingelheim Investigational Site 46	Riyadh		Saudi Arabia
57	Boehringer Ingelheim Investigational Site 47	Riyadh		Saudi Arabia
58	Boehringer Ingelheim Investigational Site 48	Riyadh		Saudi Arabia
59	Boehringer Ingelheim Investigational Site 49	Riyadh		Saudi Arabia
60	Boehringer Ingelheim Investigational Site 50	Riyadh		Saudi Arabia
61	Boehringer Ingelheim Investigational Site 51	Riyadh		Saudi Arabia
62	Boehringer Ingelheim Investigational Site 52	Riyadh		Saudi Arabia
63	Boehringer Ingelheim Investigational Site 53	Riyadh		Saudi Arabia
64	Boehringer Ingelheim Investigational Site 54	Riyadh		Saudi Arabia
65	Boehringer Ingelheim Investigational Site 55	Riyadh		Saudi Arabia
66	Boehringer Ingelheim Investigational Site 56	Riyadh		Saudi Arabia
67	Boehringer Ingelheim Investigational Site 57	Riyadh		Saudi Arabia
68	Boehringer Ingelheim Investigational Site 58	Riyadh		Saudi Arabia
69	Boehringer Ingelheim Investigational Site 59	Western Region		Saudi Arabia
70	Boehringer Ingelheim Investigational Site 60	Western Region		Saudi Arabia
71	Boehringer Ingelheim Investigational Site 61	Western Region		Saudi Arabia
72	Boehringer Ingelheim Investigational Site 62	Western Region		Saudi Arabia
73	Boehringer Ingelheim Investigational Site 63	Western Region		Saudi Arabia
74	Boehringer Ingelheim Investigational Site 64	Western Region		Saudi Arabia
75	Boehringer Ingelheim Investigational Site 65	Western Region		Saudi Arabia
76	Boehringer Ingelheim Investigational Site 66	Western Region		Saudi Arabia
77	Boehringer Ingelheim Investigational Site 67	Western Region		Saudi Arabia
78	Boehringer Ingelheim Investigational Site 68	Western Region		Saudi Arabia
79	Boehringer Ingelheim Investigational Site 69	Western Region		Saudi Arabia
80	Boehringer Ingelheim Investigational Site 70	Western Region		Saudi Arabia
81	Boehringer Ingelheim Investigational Site 71	Western Region		Saudi Arabia
82	Boehringer Ingelheim Investigational Site 72	Western Region		Saudi Arabia
83	Boehringer Ingelheim Investigational Site 73	Western Region		Saudi Arabia
84	Boehringer Ingelheim Investigational Site 74	Western Region		Saudi Arabia
85	Boehringer Ingelheim Investigational Site 75	Western Region		Saudi Arabia
86	Boehringer Ingelheim Investigational Site 76	Western Region		Saudi Arabia
87	Boehringer Ingelheim Investigational Site 77	Western Region		Saudi Arabia
88	Boehringer Ingelheim Investigational Site 78	Western Region		Saudi Arabia
89	Boehringer Ingelheim Investigational Site 79	Western Region		Saudi Arabia
90	Boehringer Ingelheim Investigational Site 80	Western Region		Saudi Arabia
91	Boehringer Ingelheim Investigational Site 81	Western Region		Saudi Arabia
92	Boehringer Ingelheim Investigational Site 82	Western Region		Saudi Arabia
93	Boehringer Ingelheim Investigational Site 83	Western Region		Saudi Arabia
94	Boehringer Ingelheim Investigational Site 84	Western Region		Saudi Arabia
95	Boehringer Ingelheim Investigational Site 85	Western Region		Saudi Arabia
96	Boehringer Ingelheim Investigational Site 86	Western Region		Saudi Arabia
97	Boehringer Ingelheim Investigational Site 87	Western Region		Saudi Arabia
98	Boehringer Ingelheim Investigational Site 88	Western Region		Saudi Arabia
99	Boehringer Ingelheim Investigational Site 89	Western Region		Saudi Arabia
100	Boehringer Ingelheim Investigational Site 90	Western Region		Saudi Arabia
101	Boehringer Ingelheim Investigational Site 91	Western Region		Saudi Arabia
102	Boehringer Ingelheim Investigational Site 113	Abu Dhabi		United Arab Emirates
103	Boehringer Ingelheim Investigational Site 114	Abu Dhabi		United Arab Emirates
104	Boehringer Ingelheim Investigational Site 115	Abu Dhabi		United Arab Emirates
105	Boehringer Ingelheim Investigational Site 116	Abu Dhabi		United Arab Emirates
106	Boehringer Ingelheim Investigational Site 117	Abu Dhabi		United Arab Emirates
107	Boehringer Ingelheim Investigational Site 118	Abu Dhabi		United Arab Emirates
108	Boehringer Ingelheim Investigational Site 119	Abu Dhabi		United Arab Emirates
109	Boehringer Ingelheim Investigational Site 120	Abu Dhabi		United Arab Emirates
110	Boehringer Ingelheim Investigational Site 102	Dubai		United Arab Emirates
111	Boehringer Ingelheim Investigational Site 103	Dubai		United Arab Emirates
112	Boehringer Ingelheim Investigational Site 104	Dubai		United Arab Emirates
113	Boehringer Ingelheim Investigational Site 105	Dubai		United Arab Emirates
114	Boehringer Ingelheim Investigational Site 106	Dubai		United Arab Emirates
115	Boehringer Ingelheim Investigational Site 107	Dubai		United Arab Emirates
116	Boehringer Ingelheim Investigational Site 108	Dubai		United Arab Emirates
117	Boehringer Ingelheim Investigational Site 109	Dubai		United Arab Emirates
118	Boehringer Ingelheim Investigational Site 110	Dubai		United Arab Emirates
119	Boehringer Ingelheim Investigational Site 111	Dubai		United Arab Emirates
120	Boehringer Ingelheim Investigational Site 112	Sharjah		United Arab Emirates

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00936208
• Other Study ID Numbers: 502.584
• First Posted: Jul 9, 2009
• Last Update Posted: Apr 10, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Micardis 80mg	Micardis Plus 80mg / 12.5mg	Total
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 Participants	1499	1596	3095
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (10.4)	53.1 (9.8)	51.5 (10.2)
Gender (participants) [Number]
Female	500 33.4%	434 27.2%	934 30.2%
Male	931 62.1%	1113 69.7%	2044 66%
Framingham score at baseline (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	15.7 (12.3)	20.6 (12.5)	18.6 (12.6)
International Renal Interest Society (IRIS) II score at baseline (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	35.8 (33.8)	37.1 (32.2)	36.1 (32.9)

Outcome Measures

1. Primary Outcome

Title	Change in Diastolic Blood Pressure From Baseline at Week 24
Description	The change from baseline reflects the week 24 value minus the baseline value.
Time Frame	Baseline and Week 24

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1462	1574
Mean (Standard Deviation) [mmHg]	-15.3 (8.6)	-18.3 (8.4)

2. Primary Outcome

Title	Change in Systolic Blood Pressure From Baseline at Week 24
Description	The change from baseline reflects the week 24 value minus the baseline value.
Time Frame	Baseline and Week 24

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1462	1574
Mean (Standard Deviation) [mmHg]	-26.6 (13.7)	-32.8 (15.0)

3. Secondary Outcome

Title	Framingham Score at Week 24
Description	The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
Time Frame	Week 24

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1349	1482
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1349	1482
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1122	1314
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1122	1314
Mean (Standard Deviation) [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)
Description	The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24
Time Frame	Baseline and Week 24

Outcome Measure Data

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
Arm/Group Description	One tablet of Micardis 80mg per day	One tablet of Micardis Plus 80 / 12.5mg per day
Measure Participants	1390	1514
Shift from baseline 0 to end-of-study 0	821 54.8%	668 41.9%
Shift from baseline 0 to end-of-study 30	21 1.4%	26 1.6%
Shift from baseline 0 to end-of-study 100	1 0.1%	9 0.6%
Shift from baseline 0 to end-of-study 500	0 0%	0 0%
Shift from baseline 30 to end-of-study 0	220 14.7%	264 16.5%
Shift from baseline 30 to end-of-study 30	114 7.6%	141 8.8%
Shift from baseline 30 to end-of-study 100	4 0.3%	0 0%
Shift from baseline 30 to end-of-study 500	0 0%	0 0%
Shift from baseline 100 to end-of-study 0	65 4.3%	90 5.6%
Shift from baseline 100 to end-of-study 30	91 6.1%	197 12.3%
Shift from baseline 100 to end-of-study 100	11 0.7%	38 2.4%
Shift from baseline 100 to end-of-study 500	0 0%	0 0%
Shift from baseline 500 to end-of-study 0	3 0.2%	12 0.8%
Shift from baseline 500 to end-of-study 30	9 0.6%	25 1.6%
Shift from baseline 500 to end-of-study 100	21 1.4%	35 2.2%
Shift from baseline 500 to end-of-study 500	9 0.6%	9 0.6%

Adverse Events

Time Frame	24 weeks
Arm/Group Title	Micardis 80mg		Micardis Plus 80mg / 12.5mg
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Micardis 80mg		Micardis Plus 80mg / 12.5mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1499 (0%)		0/1596 (0%)
Other (Not Including Serious) Adverse Events
	Micardis 80mg		Micardis Plus 80mg / 12.5mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1499 (0%)		0/1596 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.