A TElmisartan and AMlodipine STudy to Assess the cardiovascular PROTECTive effects as measured by endothelial dysfunction in hypertensive at risk patients beyond blood pressure - TEAMSTA PROTECT I

Active, not recruiting

Conditions: ?Male and female, treated and treatment-naive patients with uncontrolled hypertension (defined as 20/10 mmHg above target BP of <140/90 mmHg [<130/80 mmHg for renally impaired and/ or diabetics patients])?Male and female treated patients with controlled hypertension (defined as target BP < 140/90 mmHg [ < 130/80 mmHg for renally impaired and/ or diabetics patients])
MedDRA version: 13.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2009-017010-68-DE

Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

?Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation.
?Age 35 years or older.
?Male and female, treated and treatment-naive patients with uncontrolled hypertension (defined as 20/10 mmHg above target BP of <140/90 mmHg [<130/80 mmHg for renally impaired and/ or diabetics patients])
?Male and female treated patients with controlled hypertension (defined as target BP < 140/90 mmHg [ < 130/80 mmHg for renally impaired and/ or diabetics patients])
?> 3 CVRFs and/or metabolic syndrome and/or diabetes mellitus and/or endorgan damage (see 3.3.3)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 226

Exclusion Criteria

?Pretreatment with Telmisartan.
?Myocardial infarction within the last 6 months.
?Previous stroke or hemodynamically relevant stenosis of carotic arteria (> 70%).
?Previous cardial or peripheral bypass surgery within the last 6 months.
?PAD stadium III – IV n.F.
?Chronic heart failure NYHA III- IV.
?Instable angina.
?Known intolerance to angiotensin receptor blockers, diuretics or dihydropyridine calcium cannel blocker.