Telmisartan, Amlodipine and Flow Mediated Dilation (TEAMSTAprotect)
Drug: Olmesartan medoxomil
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- FMD flow mediated dilation [ Time Frame: baseline ]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.
- FMD [ Time Frame: after 26 weeks ]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.
- Echogenicity [ Time Frame: baseline ]To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques
- arterial stiffness [ Time Frame: baseline ]To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness
- arterial stiffness [ Time Frame: after 26 weeks ]To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness
- Echogenicity [ Time Frame: after 26 weeks ]To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: T/A
Telmisartan + Amlopidpine
Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)
Other Name: MICARDIS® (Telmisartan)Drug: Amlodipine
Amlodpine 5 mg po 14 days, the forced - titration to 10 mg po for 24 weeks
Other Name: Norvasc
Active Comparator: O/HCT
Olmesartan + Hydrochlorothiazide
Drug: Olmesartan medoxomil
Olmesartan 40 mg po for 26 weeks
Other Name: OlmetecDrug: Hydrochlorothiazide
HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180205
|Mainz, Rheinland-Pfalz, Germany, 55131|
|Principal Investigator:||Stefan Blankenberg, Prof.Dr.med.||Universitätsmedizin Mainz, II.Medizinische Klinik|