Comparative Study of the Effects of Telmisartan and Nebivolol

Summary

Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective beta-adrenergic blockers in treatment of arterial hypertension and in improvement of arterial stiffness has been established in previous studies among the hypertensive population. The present study is a comparison of the performance of two drugs, telmisartan and nebivolol, in 24h ambulatory blood pressure values and in the degree of arterial stiffness of patients with stage I arterial hypertension.

Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement devices and the method of pulse-wave velocity analysis. The effects of telmisartan and nebivolol are going to be compared for a total time period of 12 months.

The aim of this project is to determine whether the expected decrease in arterial stiffness of subjects with stage I arterial hypertension can be attributed to the blood pressure fall solely, or to other factors as well. These factors are possibly dependent on the action of these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral vasodilatory actions.

The present study is going to be the first comparative test of the anti-hypertensive effects of the two pharmaceutical substances in 12 months' time, and of the elimination of total cardiovascular risk in terms of primary prevention of cardiovascular attacks.

Conditions

• Hypertension

Interventions

DRUG

TELMISARTAN

Patients of the group of telmisartan will take 40 mg of telmisartan daily in the morning. At the end of the first month of treatment, patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. Patients still classified in the stage I hypertensive range will receive 80 mg of telmisartan daily in the morning. At the end of the 6th month from the beginning of the study patients classified in the normal BP range will continue on the same medication scheme. For patients still classified in the stage I hypertensive range12,5 mg of hydrochlorothiazide will be added. The end of the 12-month period from the beginning of the study indicates the completion of the project.

DRUG

NEBIVOLOL

Patients will take 5 mg of nebivolol daily in the morning. At the end of the first month of treatment, patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. Patients classified in the stage I hypertensive range the nebivolol group will receive 10 mg of nebivolol daily in the morning. At the end of the 6th month from the beginning of the study patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. For patients classified in the stage I hypertensive range 12,5 mg of hydrochlorothiazide will be added. The end of the 12-month period from the beginning of the study indicates the completion of the project

Sponsors & Collaborators

• Aristotle University Of Thessaloniki

  lead OTHER

Principal Investigators

• Sofia Papakatsika, MD · AUTH

• Vasilios Kotsis, MD,Ph.D · AUTH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2015-01-31

Completion

2017-01-31

Countries

• Greece

Study Locations