Clinical trial NCT00936208: PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 3184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Diastolic Blood Pressure From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Change in Systolic Blood Pressure From Baseline at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Framingham Score at Week 24
timeFrame: Week 24
measure: Change in the Framingham Score From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: International Renal Interest Society (IRIS) II Score at Week 24
timeFrame: Week 24
measure: Change in the IRIS II Score From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Alexandria West
country: Egypt
facility: Boehringer Ingelheim Investigational Site 16
city: Alexandria West
country: Egypt
facility: Boehringer Ingelheim Investigational Site 17
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 18
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 19
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 20
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 21
city: Assiut
country: Egypt
facility: Boehringer Ingelheim Investigational Site 29
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 10
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 11
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 12
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 1
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 2
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 3
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 4
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 5
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 6
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 7
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 8
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 9
city: Domiat
country: Egypt
facility: Boehringer Ingelheim Investigational Site 22
city: El Garbia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 23
city: El Minia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 14
city: El Minia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 15
city: Fakous - El Sharkia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 25
city: Fayoum
country: Egypt
facility: Boehringer Ingelheim Investigational Site 28
city: Kalioubya
country: Egypt
facility: Boehringer Ingelheim Investigational Site 13
city: Mansoura - El Dakahlia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 27
city: Menofia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 30
city: Poert said
country: Egypt
facility: Boehringer Ingelheim Investigational Site 24
city: Zagazig - El Sharkia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 26
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 100
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 101
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 92
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 93
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 94
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 95
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 96
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 97
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 98
city: Eastern Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 99
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 31
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 32
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 33
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 34
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 35
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 36
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 37
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 38
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 39
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 40
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 41
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 42
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 43
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 44
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 45
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 46
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 47
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 48
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 49
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 50
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 51
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 52
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 53
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 54
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 55
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 56
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 57
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 58
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 59
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 60
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 61
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 62
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 63
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 64
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 65
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 66
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 67
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 68
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 69
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 70
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 71
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 72
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 73
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 74
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 75
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 76
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 77
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 78
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 79
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 80
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 81
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 82
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 83
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 84
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 85
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 86
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 87
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 88
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 89
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 90
city: Western Region
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 91
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 113
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 114
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 115
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 116
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 117
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 118
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 119
city: Abu Dhabi
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 120
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 102
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 103
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 104
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 105
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 106
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 107
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 108
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 109
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 110
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 111
city: Sharjah
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 112
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: