PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00936208
First received: July 8, 2009
Last updated: May 23, 2012
Last verified: May 2012
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Purpose
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 |
|---|
|
Hypertension |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Telmisartan
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Change in Diastolic Blood Pressure From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The change from baseline reflects the week 24 value minus the baseline value.
Secondary Outcome Measures:
- Framingham Score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).
- Change in the Framingham Score From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]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).
- International Renal Interest Society (IRIS) II Score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]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 IRIS II Score From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]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 From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24
| Enrollment: | 3184 |
| Study Start Date: | May 2009 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Essential hypertensive men and women |
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936208
Show 120 Study Locations
Show 120 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00936208 History of Changes |
| Other Study ID Numbers: | 502.584 |
| Study First Received: | July 8, 2009 |
| Results First Received: | April 19, 2012 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Egypt: Ministry of Health and Population Saudi Arabia: Ministry of Health United Arab Emirates: General Auth for Health Services Abu Dhabi |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Telmisartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013