Comparative Study of the Effects of Telmisartan and Nebivolol

NCT02057328 | Unknown Phase 4

• 1 other identifier: TELNEB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change from baseline in 24h blood pressure

  Change in 24h BP values in patients with stage I arterial hypertension treated with telmisartan and nebivolol

  1,6,12 months

• Change from baseline in arterial stiffness

  Change in arterial stiffness in patients with stage I arterial hypertension treated with telmisartan and nebivolol

  1,6,12 months

Study Arms (2)

NEBIVOLOL

ACTIVE COMPARATOR

Patients of the group of nebivolol 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 (24h SBP/DBP \< 130/80 mm Hg) will continue on the same medication scheme. Patients still 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 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 12,5 mg 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

TELMISARTAN

ACTIVE COMPARATOR

Patients of the group of telmisartan will take 40 mg of telmisarta 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 (24h SBP/DBP \< 130/80 mm Hg) will continue on the same medication scheme. Patients classified in the stage I hypertensive range will receive 80 mg of telmisartan daily in the morning. The same procedure will be repeated 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: TELMISARTAN

Interventions

TELMISARTAN DRUG

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.

Also known as: MICARDIS

TELMISARTAN

NEBIVOLOL DRUG

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

Also known as: LOBIVON

NEBIVOLOL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension \[increased office BP values (SBP/DBP ≥ 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP \< 130/80 mm Hg)\] will also be excluded from the study.
• All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test).

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hypertension-ABPM Center 3rd department of Internal Medicine

Thessaloniki, Greece

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Sofia Papakatsika, MD

  AUTH

  PRINCIPAL INVESTIGATOR

• Vasilios Kotsis, MD,Ph.D

  AUTH

  STUDY CHAIR

Central Study Contacts

Vasilios Kotsis, MD,Ph.D

CONTACT

+306974748860; vkotsis@auth.gr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROF. MEDICINE

Study Record Dates

• First Submitted: October 27, 2013
• First Posted: February 7, 2014
• Study Start: December 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2017
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

GR (1)