HypertensionNCT00936208

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

An observational study of Hypertension, run by Boehringer Ingelheim at 120 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension
How many people: 3,184 participants
Where: 120 sitesin 3 countries
Study dates: May 2009to Nov 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

120 sites in 3 countries.

Country

City, postcode or hospital

120 sites in 3 countries

Saudi Arabia71 sites

Boehringer Ingelheim Investigational Site 100
Eastern Region
Boehringer Ingelheim Investigational Site 101
Eastern Region
Boehringer Ingelheim Investigational Site 92
Eastern Region
Boehringer Ingelheim Investigational Site 93
Eastern Region
Boehringer Ingelheim Investigational Site 94
Eastern Region
Boehringer Ingelheim Investigational Site 95
Eastern Region
Boehringer Ingelheim Investigational Site 96
Eastern Region
Boehringer Ingelheim Investigational Site 97
Eastern Region
Boehringer Ingelheim Investigational Site 98
Eastern Region
Boehringer Ingelheim Investigational Site 99
Eastern Region
Boehringer Ingelheim Investigational Site 31
Riyadh
Boehringer Ingelheim Investigational Site 32
Riyadh
Boehringer Ingelheim Investigational Site 33
Riyadh
Boehringer Ingelheim Investigational Site 34
Riyadh
Boehringer Ingelheim Investigational Site 35
Riyadh
Boehringer Ingelheim Investigational Site 36
Riyadh
Boehringer Ingelheim Investigational Site 37
Riyadh
Boehringer Ingelheim Investigational Site 38
Riyadh
Boehringer Ingelheim Investigational Site 39
Riyadh
Boehringer Ingelheim Investigational Site 40
Riyadh
Boehringer Ingelheim Investigational Site 41
Riyadh
Boehringer Ingelheim Investigational Site 42
Riyadh
Boehringer Ingelheim Investigational Site 43
Riyadh
Boehringer Ingelheim Investigational Site 44
Riyadh
Boehringer Ingelheim Investigational Site 45
Riyadh
Boehringer Ingelheim Investigational Site 46
Riyadh
Boehringer Ingelheim Investigational Site 47
Riyadh
Boehringer Ingelheim Investigational Site 48
Riyadh
Boehringer Ingelheim Investigational Site 49
Riyadh
Boehringer Ingelheim Investigational Site 50
Riyadh
Boehringer Ingelheim Investigational Site 51
Riyadh
Boehringer Ingelheim Investigational Site 52
Riyadh
Boehringer Ingelheim Investigational Site 53
Riyadh
Boehringer Ingelheim Investigational Site 54
Riyadh
Boehringer Ingelheim Investigational Site 55
Riyadh
Boehringer Ingelheim Investigational Site 56
Riyadh
Boehringer Ingelheim Investigational Site 57
Riyadh
Boehringer Ingelheim Investigational Site 58
Riyadh
Boehringer Ingelheim Investigational Site 59
Western Region
Boehringer Ingelheim Investigational Site 60
Western Region
Boehringer Ingelheim Investigational Site 61
Western Region
Boehringer Ingelheim Investigational Site 62
Western Region
Boehringer Ingelheim Investigational Site 63
Western Region
Boehringer Ingelheim Investigational Site 64
Western Region
Boehringer Ingelheim Investigational Site 65
Western Region
Boehringer Ingelheim Investigational Site 66
Western Region
Boehringer Ingelheim Investigational Site 67
Western Region
Boehringer Ingelheim Investigational Site 68
Western Region
Boehringer Ingelheim Investigational Site 69
Western Region
Boehringer Ingelheim Investigational Site 70
Western Region
Boehringer Ingelheim Investigational Site 71
Western Region
Boehringer Ingelheim Investigational Site 72
Western Region
Boehringer Ingelheim Investigational Site 73
Western Region
Boehringer Ingelheim Investigational Site 74
Western Region
Boehringer Ingelheim Investigational Site 75
Western Region
Boehringer Ingelheim Investigational Site 76
Western Region
Boehringer Ingelheim Investigational Site 77
Western Region
Boehringer Ingelheim Investigational Site 78
Western Region
Boehringer Ingelheim Investigational Site 79
Western Region
Boehringer Ingelheim Investigational Site 80
Western Region
Boehringer Ingelheim Investigational Site 81
Western Region
Boehringer Ingelheim Investigational Site 82
Western Region
Boehringer Ingelheim Investigational Site 83
Western Region
Boehringer Ingelheim Investigational Site 84
Western Region
Boehringer Ingelheim Investigational Site 85
Western Region
Boehringer Ingelheim Investigational Site 86
Western Region
Boehringer Ingelheim Investigational Site 87
Western Region
Boehringer Ingelheim Investigational Site 88
Western Region
Boehringer Ingelheim Investigational Site 89
Western Region
Boehringer Ingelheim Investigational Site 90
Western Region
Boehringer Ingelheim Investigational Site 91
Western Region

Other trials in Saudi Arabia

Egypt30 sites

Boehringer Ingelheim Investigational Site 28
Al Fayyum
Boehringer Ingelheim Investigational Site 18
Alexandria
Boehringer Ingelheim Investigational Site 19
Alexandria
Boehringer Ingelheim Investigational Site 20
Alexandria
Boehringer Ingelheim Investigational Site 21
Alexandria
Boehringer Ingelheim Investigational Site 16
Alexandria West
Boehringer Ingelheim Investigational Site 17
Alexandria West
Boehringer Ingelheim Investigational Site 29
Asyut
Boehringer Ingelheim Investigational Site 10
Cairo
Boehringer Ingelheim Investigational Site 11
Cairo
Boehringer Ingelheim Investigational Site 12
Cairo
Boehringer Ingelheim Investigational Site 1
Cairo
Boehringer Ingelheim Investigational Site 2
Cairo
Boehringer Ingelheim Investigational Site 3
Cairo
Boehringer Ingelheim Investigational Site 4
Cairo
Boehringer Ingelheim Investigational Site 5
Cairo
Boehringer Ingelheim Investigational Site 6
Cairo
Boehringer Ingelheim Investigational Site 7
Cairo
Boehringer Ingelheim Investigational Site 8
Cairo
Boehringer Ingelheim Investigational Site 9
Cairo
Boehringer Ingelheim Investigational Site 22
Domiat
Boehringer Ingelheim Investigational Site 23
El Garbia
Boehringer Ingelheim Investigational Site 25
Fakous - El Sharkia
Boehringer Ingelheim Investigational Site 13
Kalioubya
Boehringer Ingelheim Investigational Site 27
Mansoura - El Dakahlia
Boehringer Ingelheim Investigational Site 30
Menofia
Boehringer Ingelheim Investigational Site 14
Minya
Boehringer Ingelheim Investigational Site 15
Minya
Boehringer Ingelheim Investigational Site 24
Poert Said
Boehringer Ingelheim Investigational Site 26
Zagazig - El Sharkia

Other trials in Egypt

United Arab Emirates19 sites

Boehringer Ingelheim Investigational Site 113
Abu Dhabi
Boehringer Ingelheim Investigational Site 114
Abu Dhabi
Boehringer Ingelheim Investigational Site 115
Abu Dhabi
Boehringer Ingelheim Investigational Site 116
Abu Dhabi
Boehringer Ingelheim Investigational Site 117
Abu Dhabi
Boehringer Ingelheim Investigational Site 118
Abu Dhabi
Boehringer Ingelheim Investigational Site 119
Abu Dhabi
Boehringer Ingelheim Investigational Site 120
Abu Dhabi
Boehringer Ingelheim Investigational Site 102
Dubai
Boehringer Ingelheim Investigational Site 103
Dubai
Boehringer Ingelheim Investigational Site 104
Dubai
Boehringer Ingelheim Investigational Site 105
Dubai
Boehringer Ingelheim Investigational Site 106
Dubai
Boehringer Ingelheim Investigational Site 107
Dubai
Boehringer Ingelheim Investigational Site 108
Dubai
Boehringer Ingelheim Investigational Site 109
Dubai
Boehringer Ingelheim Investigational Site 110
Dubai
Boehringer Ingelheim Investigational Site 111
Dubai
Boehringer Ingelheim Investigational Site 112
Sharjah city

Other trials in United Arab Emirates

About this study

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

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

Conditions: Hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00936208
Study group	Role	What they receive
Essential hypertensive men and women		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Diastolic Blood Pressure From Baseline at Week 24
The change from baseline reflects the week 24 value minus the baseline value.
Measured: Baseline and Week 24
Change in Systolic Blood Pressure From Baseline at Week 24
The change from baseline reflects the week 24 value minus the baseline value.
Measured: Baseline and Week 24

Secondary outcomes (5)

Framingham Score at Week 24
The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
Measured: Week 24
Change in the Framingham Score From Baseline 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).
Measured: Baseline and Week 24
International Renal Interest Society (IRIS) II Score 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).
Measured: Week 24
Change in the IRIS II Score From Baseline 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).
Measured: Baseline and Week 24
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Nov 2010

First posted9 Jul 2009 (estimated)
Study startMay 2009
Primary completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00936208
Sponsor's protocol ID: 502.584
Status last verified: Mar 2014
First submitted: 8 Jul 2009
Last updated: 10 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00936208
Acronym / sponsor ID: 502.584
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 3,184 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Nov 2010 (actual)
First posted: 9 Jul 2009 (estimated)
Results: Posted 2 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Essential hypertensive men and women	–	–

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Diastolic Blood Pressure From Baseline at Week 24
Time frame: Baseline and Week 24
The change from baseline reflects the week 24 value minus the baseline value.
Change in Systolic Blood Pressure From Baseline at Week 24
Time frame: Baseline and Week 24
The change from baseline reflects the week 24 value minus the baseline value.

5 secondary outcomes

Framingham Score at Week 24
Time frame: Week 24
Change in the Framingham Score From Baseline at Week 24
Time frame: Baseline and Week 24
International Renal Interest Society (IRIS) II Score at Week 24
Time frame: Week 24
Change in the IRIS II Score From Baseline at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 2 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Micardis 80mg	1,499	1,462
Micardis Plus 80mg / 12.5mg	1,596	1,574

Primary outcome: Change in Diastolic Blood Pressure From Baseline at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: mmHg

Measure	Micardis 80mg n = 1462	Micardis Plus 80mg / 12.5mg n = 1574
Value	-15.3 (8.6)	-18.3 (8.4)

Population analysed: Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24

Primary outcome: Change in Systolic Blood Pressure From Baseline at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: mmHg

Measure	Micardis 80mg n = 1462	Micardis Plus 80mg / 12.5mg n = 1574
Value	-26.6 (13.7)	-32.8 (15.0)

Population analysed: Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Micardis 80mg	0 of 1,499 (0%)	0 of 1,499 (0%)	Not reported
Micardis Plus 80mg / 12.5mg	0 of 1,596 (0%)	0 of 1,596 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

120 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 120 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in Saudi Arabia, Egypt, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Diastolic Blood Pressure From Baseline at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00936208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.