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Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function (NEMENDAS)

This study has been completed.
Sponsor:
Information provided by:
Berlin-Chemie AG Menarini Group
ClinicalTrials.gov Identifier:
NCT01248338
First received: November 19, 2010
Last updated: November 24, 2010
Last verified: November 2010
History of Changes
  Purpose

An impairment of endothelial function plays the central role in the pathogenesis of cardiovascular diseases and their complications. Most of cardiovascular risk factors are known to impair endothelial function and the established disease further aggravates endothelial dysfunction.

The aim of the present study is to investigate the effects of nebivolol or metoprolol succinate on endothelial function and large artery stiffness.


Condition Intervention Phase
Hypertension
 Drug: metoprolol succinate
Drug: Nebivolol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison the Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function and Large Artery Stiffness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Berlin-Chemie AG Menarini Group:

Primary Outcome Measures:
  • Effects of nebivolol and metoprolol on endothelial function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    High-fidelity micromanometer (applanation tonometry) from both wrists and PWA, which is to be performed of the systolic portion (SphygmoCor Px, version 7.0) of the pulse curve.


Secondary Outcome Measures:
  • Change in carotid artery intima-media thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Ultrasound scanner,with an 12 MHz transducer. Longitudinal images from 3 projections (anterolateral, lateral, and posterolateral) are measured for the common carotid artery, carotid bulb, and internal carotid artery

  • Change in left ventricular mass index, systolic and diastolic function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    2-dimensional echocardiography using the standard apical 4-chamber view

  • Arterial Compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Peripheral blood pressure and arterial waveform to be measured in the dominant arm by a Cardiovascular Profiling Instrument


Enrollment: 80
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metoprolol, tablets
metoprolol succinate 50-100 mg orally daily for one year
 Drug: metoprolol succinate
once daily 50 or 100 mg for one year
Other Name: Corvitol
Experimental: nebivolol
nebivolol 5 mg capsule once daily for one year
 Drug: Nebivolol
once daily 5 mg capsule for one year
Other Name: Nebilet

Detailed Description:

The aim of this study was to compare the effects between the vasodilating β-blocker nebivolol and the cardioselective β-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness. We conducted a randomized, double-blind study in 80 hypertensive patients. Patients received either nebivolol 5 mg or metoprolol succinate 50-100 mg daily for one year. Their heart rate, central and brachial blood pressure, mean arterial pressure, augmentation index, carotid-femoral pulse wave velocity and left ventricular wall thickness were measured at baseline and at the end of the study.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild to moderate essential hypertension (systolic BP 140-179 mmHg and/or diastolic BP 90-109 mmHg)*
  • Male and female patients aged 30-65 years Newly diagnosed untreated patients or previously diagnosed patients who were without treatment at least two weeks prior to screening* If patient has been taken previously antihypertensive medication the BP values are originated after untreated two weeks before randomization

Exclusion Criteria:

  • Concomitant medication: Cyclic antidepressants, MAO inhibitors, corticosteroids
  • Diabetes I or II type (fasting venous plasma glucose > 6.4 mmol/l)
  • Bronchial asthma and chronic obstructive airway disease
  • Body mass index > 30 kg/m2
  • Ischaemic heart disease (III, IV stage, Canadian Cardiovascular Society)
  • Clinically relevant heart failure (NYHA class II - IV)
  • Clinically relevant valve disease (physical examination)
  • Arrhythmias and conduction disturbances, requiring therapy, sinus bradycardia at rest < 50 b/min, sick sinus syndrome, AV - block stage II - III
  • Secondary hypertension (urea >8.3 mmol/l, creatinine >120μmol/l (males), >103 μmol/l (females), TSH > 4.0mIU/l, free T4 > 27 pmol/l)
  • Clinically relevant atherosclerotic disease of lower extremities
  • Acute inflammation (according to CRP > 10mg/l)
  • Hypercholesterolemia (> 6,5 mmol/l)
  • Allergic reaction to beta-blockers
  • Pregnant or breast-feeding women
  • History of hepatic, renal, metabolic or endocrine diseases
  • Smoking > 10 cigarettes per day
  • Alcohol consumption > 7 drinks per week (drink = 0,33 l beer, 120 ml wine or 30 ml strong alcoholic drink)
  • The patient has had surgery or disease of the gastrointestinal tract which, in the opinion of the investigator, may influence the absorption or elimination of the study drug.
  • The patient has a severe organic disorder that may interfere with the absorption, pharmacokinetics, or elimination of the study medication.
  • The patient has a comorbid condition that would be expected to result in death during the trial period (e.g., terminal cancer, AIDS).
  • The patient has chronic psychoses or behavioural conditions that would limit the ability of the patient to comply with the requirements of this study.
  • The patient has known hypersensitivity to Nebivolol, Metoprolol or hydrochlorothiazide related compounds.
  • Patient is enrolled in another clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248338

Locations
Estonia
Cardiology Clinic of Tartu University Clinics
Tartu, Estonia, 51014
Sponsors and Collaborators
Berlin-Chemie AG Menarini Group
Investigators
Principal Investigator: Jaan Eha, Professor Cardiology Clinic of Tartu University Clinics
  More Information

No publications provided by Berlin-Chemie AG Menarini Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaltwasser, Maria Theresia, Dr., Berlin-Chemie AG Menarini Group
ClinicalTrials.gov Identifier: NCT01248338     History of Changes
Other Study ID Numbers: MeES/05/Neb-EnD/001
Study First Received: November 19, 2010
Last Updated: November 24, 2010
Health Authority: Estonia: The State Agency of Medicine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
 Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 21, 2013