Hypertension Clinical Trial
Official title:
A TElmisartan and AMlodipine STudy to Assess the Cardiovascular PROTECTive Effects as Measured by Endothelial Dysfunction in Hypertensive at Risk Patients Beyond Blood Pressure
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no medication is stopped without having been replaced by the study medication.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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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