Comparative Study of the Effects of Telmisartan and Nebivolol (TELNEB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by (Responsible Party):
Vasilios Kotsis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT02057328
First received: October 27, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: TELMISARTAN
Drug: NEBIVOLOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of the Effects of Telmisartan and Nebivolol on 24-h Ambulatory Blood Pressure and Arterial Stiffness in Patients With Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Change from baseline in 24h blood pressure [ Time Frame: 1,6,12 months ] [ Designated as safety issue: No ]
    Change in 24h BP values in patients with stage I arterial hypertension treated with telmisartan and nebivolol

  • Change from baseline in arterial stiffness [ Time Frame: 1,6,12 months ] [ Designated as safety issue: No ]
    Change in arterial stiffness in patients with stage I arterial hypertension treated with telmisartan and nebivolol


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NEBIVOLOL
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
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
Other Name: LOBIVON
Active Comparator: TELMISARTAN
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
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.
Other Name: MICARDIS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: The final selection of the sample of 80 patients diagnosed with stage I arterial hypertension will be based on the ABPM results (24h SBP/DBP ≥ 130/80 mm Hg).

Exclusion Criteria:

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057328

Contacts
Contact: Vasilios Kotsis, MD,Ph.D +306974748860 vkotsis@auth.gr

Locations
Greece
Hypertension-ABPM Center 3rd department of Internal Medicine Recruiting
Thessaloniki, Greece
Contact: Vasilios Kotsis, MD, Ph.D    +306974748860    vkotsis@auth.gr   
Principal Investigator: Sofia Papakatsika, MD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Sofia Papakatsika, MD AUTH
Study Chair: Vasilios Kotsis, MD,Ph.D AUTH
  More Information

No publications provided

Responsible Party: Vasilios Kotsis, PROF. MEDICINE, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02057328     History of Changes
Other Study ID Numbers: TELNEB
Study First Received: October 27, 2013
Last Updated: February 5, 2014
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Nebivolol
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014