To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by flow mediated dilation (FMD) in hypertensive at risk patients beyond bloodpressure BP (equal BP in both arms; target BP \<140/90 mmHg (\<130/80 mmHg for renally impaired and/ or diabetic patients). To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness and carotid atherosclerotic plaques.
This is a Phase IV, randomised, double-blind, forced- titration, active controlled, mono-center study to primarily compare the effects on endothelial function of the combination of telmisartan and amlodipine versus olmesartan and hydrochlorothiazide in hypertensive patients at risk beyond blood pressure. Additionally, key secondary endpoints for this trial are the changes in plaque and intima media complex echogenicity and the change in arterial stiffness after 26 weeks of treatment. 576 patients will be included in the study after a screening period of two weeks and then randomised in one of the two treatment groups. Pretreatment with ARBs, ACE-Inhibitors, amlodipine and diuretics will be stopped last day before visit 2. At visit 2 the treatment with either telmisartan and amlodipine or olmesartan and hydrochlorothiazide starts, so that no medication is stopped without having been replaced by the study medication. After two weeks treatment all patients will be up-titrated and having the maintenance dose for the following 24 weeks. The trial will be performed at one center in Germany with access to patients with hypertension. Patients will be recruited from the Department of Cardiology of the university Mainz. There will be a promotion flyer and an information booklet about the study for cardiologists practicising near Mainz, who like to sent their patient to the study center. Sponsor of the trial is the university Mainz. Stefan Blankenberg, MD has been designated as Principal Investigator for this national, mono-center trial. The study will be completed when the last patient had his last visit and the telephone follow - up two weeks later will be performed. This latest patient contact is defined as end of trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
576
Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)
Amlodpine 5 mg po 14 days, the forced - titration to 10 mg po for 24 weeks
Olmesartan 40 mg po for 26 weeks
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
FMD flow mediated dilation
The overall mean improvement following 26 weeks of treatment in FMD as measured by the change from Visit 2 for T80/A10 is equal to O40/H25.
Time frame: baseline
FMD
The overall mean improvement following 26 weeks of treatment in FMD as measured by the change from Visit 2 for T80/A10 is equal to O40/H25.
Time frame: after 26 weeks
Echogenicity
To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques
Time frame: baseline
arterial stiffness
To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness
Time frame: baseline
arterial stiffness
To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness
Time frame: after 26 weeks
Echogenicity
To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques
Time frame: after 26 weeks
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HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks