NCT01180205

Telmisartan, Amlodipine and Flow Mediated Dilation

A TElmisartan and AMlodipine STudy to Assess the Cardiovascular PROTECTive Effects as Measured by Endothelial Dysfunction in Hypertensive at Risk Patients Beyond Blood Pressure

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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and amlodipine or olmesartan and hydrochlorothiazide starts, so that no medication is stopped without having been replaced by the study medication.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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Telmisartan	Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)
DRUG	Amlodipine	Amlodpine 5 mg po 14 days, the forced - titration to 10 mg po for 24 weeks
DRUG	Olmesartan medoxomil	Olmesartan 40 mg po for 26 weeks
DRUG	Hydrochlorothiazide	HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-08-12
• Last updated: 2011-07-12

Locations

1 site across 1 country: Germany