Telmisartan, Amlodipine and Flow Mediated Dilation (TEAMSTAprotect)
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|ClinicalTrials.gov Identifier: NCT01180205|
Recruitment Status : Unknown
Verified April 2010 by Johannes Gutenberg University Mainz.
Recruitment status was: Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : July 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Telmisartan Drug: Amlodipine Drug: Olmesartan medoxomil Drug: Hydrochlorothiazide||Phase 4|
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and amlodipine or olmesartan and hydrochlorothiazide starts, so that no medication is stopped without having been replaced by the study medication.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 (Clinical Trial)|
|Estimated Enrollment :||576 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2011|
Active Comparator: T/A
Telmisartan + Amlopidpine
Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)
Other Name: MICARDIS® (Telmisartan)
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: Olmetec
HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180205
|Mainz, Rheinland-Pfalz, Germany, 55131|
|Principal Investigator:||Stefan Blankenberg, Prof.Dr.med.||Universitätsmedizin Mainz, II.Medizinische Klinik|