? 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: 13.1 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disord
Conditions
Interventions
Trade Name: Micardis® 40 mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: TELMISARTAN
CAS Number: 144701-48-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs Olmesartan and HCTZ (O and HCTZ) on endothelial dysfunction as measured by flow mediated dilation (FMD) in hypertensive at risk patients beyond BP (equal BP in both arms; target BP <140/90 mmHg (<130/80 mmHg for renally impaired and/ or diabetic patients) including response dependent add-on of other antihypertensive);Secondary Objective: ? To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness (as measured by PWV and AI) and carotid atherosclerotic plaques.;Primary end point(s): ? Change in endothelial function as measured by flow mediated dilatation (FMD) after 26 weeks of treatment compared to baseline ;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in stiffness measurement and pulse wave velocity after 26 weeks of treatment compared to baseline • Change in plaque echogenicity as measured by grayscale median (GSM) of the carotid arteria after 26 weeks of treatment compared to baseline • Change in blood pressure control rates (i.e. <140/90 mmHg and <130/80 mmHg for diabetics and renally impaired patients) after 6, 12 and 26 weeks compared to baseline • Change in intima media echogenicity as measured by grayscale median (GSM) of the carotid arteria after 26 weeks of treatment compared to baseline • Type and amount of additional antihypertensive medication after 12 and 26 weeks compared to baseline • Change in additional functional and inflammatory biomarkers compared to baseline;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Countries
Germany
Contacts
Public ContactII. Medizinische Klinik und Polikli
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Outcome results
None listed