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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00936208

Enrollment

3184

Registered

2009-07-09

Start date

2009-05-31

Completion date

Unknown

Last updated

2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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

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

Countries

Egypt, Saudi Arabia, United Arab Emirates

Participant flow

Pre-assignment details

3184 patients were enrolled but treatment was unknown in 89 patients. Therefore, 3095 patients were analysed.

Participants by arm

Arm	Count
Micardis 80mg One tablet of Micardis 80mg per day	1,499
Micardis Plus 80mg / 12.5mg One tablet of Micardis Plus 80 / 12.5mg per day	1,596
Total	3,095

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	37	22

Baseline characteristics

Characteristic	Total	Micardis 80mg	Micardis Plus 80mg / 12.5mg
Age, Continuous	51.5 years STANDARD_DEVIATION 10.2	49.8 years STANDARD_DEVIATION 10.4	53.1 years STANDARD_DEVIATION 9.8
Framingham score at baseline	18.6 Units on a scale STANDARD_DEVIATION 12.6	15.7 Units on a scale STANDARD_DEVIATION 12.3	20.6 Units on a scale STANDARD_DEVIATION 12.5
Gender Female	934 participants	500 participants	434 participants
Gender Male	2044 participants	931 participants	1113 participants
International Renal Interest Society (IRIS) II score at baseline	36.1 Units on a scale STANDARD_DEVIATION 32.9	35.8 Units on a scale STANDARD_DEVIATION 33.8	37.1 Units on a scale STANDARD_DEVIATION 32.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 1,499	0 / 1,596
serious Total, serious adverse events	0 / 1,499	0 / 1,596