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Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol

NCT00942487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-07-21

No results posted yet for this study

Summary

Summary:

* Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study)
* Study phase: 3
* Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled, open label
* Study treatment(s)/drug(s): Nebivolol versus Metoprolol
* Patients:

* characteristics: patients with hypertension and left ventricular hypertrophy
* planned total number: 50
* Study duration:

* total enrolment period (months): 18
* treatment period (months): 6
* follow up period (months): 6
* Total study duration (months): 24

* Number of Centres: 1
* Country(ies): Romania (RO)

Conditions

  • Primary Arterial Hypertension

Interventions

DRUG

Nebilet

Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration

DRUG

Corvitol

Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration

Sponsors & Collaborators

  • Berlin-Chemie Menarini

    lead INDUSTRY

Principal Investigators

  • Dragos VINEREANU, MD · University and Emergency Hospital Bucharest, Romania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-12-31
Completion
2009-07-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00942487 on ClinicalTrials.gov