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

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, January 2010

First Received: July 8, 2009 Last Updated: January 13, 2010 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00936208

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:	Cohort, 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 from baseline in systolic and diastolic blood pressure on week 24 after treatment with either Telmisartan 80 mg (Micardis) or with Telmisartan Plus 80/12.5 mg (Micardis Plus). Incidence of serious adverse events reported during 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Screen enrolled patients for the prevalence of microalbuminuria at baseline and 24 weeks visits Calculate cardiovascular risk factor with the Risk calculator using Framingham score and IRIS II [ Time Frame: 24 weeks ]

Estimated Enrollment:	3600
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 102 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	502.584
Study First Received:	July 8, 2009
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00936208 History of Changes
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:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Telmisartan
Pharmacologic Actions
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010