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

Condition(s) targeted: Hypertension

Phase: N/A

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

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

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 design: Cohort, Prospective

Primary outcome: 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

Secondary outcome: 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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

Boehringer Ingelheim Investigational Site 1, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 2, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 3, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 4, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 5, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 6, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 7, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 8, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 9, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 10, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 11, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 12, Cairo, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, Kalioubya, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, El Minia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 2, El Minia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, Alexandria West, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 2, Alexandria West, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, Alexandria, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 2, Alexandria, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 3, Alexandria, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 4, Alexandria, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, Domiat, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, El Garbia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, Poert said, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, Fakous - El Sharkia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, Zagazig- El Sharkia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, Mansoura - El Dakahlia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, Fayoum, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, Assiut, Egypt; Recruiting

Boehringer Ingelheim Investigational Site, Menofia, Egypt; Recruiting

Boehringer Ingelheim Investigational Site 1, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 2, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 3, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 4, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 5, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 6, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 7, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 8, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 9, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 10, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 11, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 12, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 13, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 14, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 15, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 16, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 17, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 18, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 19, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 20, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 21, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 22, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 23, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 24, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 25, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 26, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 27, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 28, Riyadh, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 1, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 2, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 3, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 4, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 5, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 6, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 7, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 8, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 9, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 10, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 11, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 12, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 13, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 14, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 15, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 16, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 17, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 18, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 19, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 20, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 21, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 22, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 23, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 24, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 25, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 26, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 27, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 28, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 29, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 30, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 31, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 32, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 33, Western Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 1, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 2, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 3, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 4, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 5, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 6, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 7, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 8, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 9, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 10, Eastern Region, Saudi Arabia; Recruiting

Boehringer Ingelheim Investigational Site 1, Sharjah, United Arab Emirates; Recruiting

Boehringer Ingelheim Investigational Site 2, Dubai, United Arab Emirates; Recruiting

Starting date: May 2009
Last updated: September 3, 2009