NCT00942487: ENESYS

Effects of NEbivolol on Subclinical Left Ventricular dYSfunction. A Comparative Study Against Metoprolol. The ENESYS Study. A Phase 3, Randomised, Parallel, Active-controlled, Open Label Study

Completed Phase 3 Last updated 20 July 2009

What this trial tests

Phase 3 trial testing Nebilet in Primary Arterial Hypertension in 60 participants. Completed in 1 July 2009.

Timeline

1 April 2005

Primary endpoint
1 December 2008

1 July 2009

Quick facts

Lead sponsor	Berlin-Chemie Menarini
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 April 2005
Primary completion	1 December 2008
Estimated completion	1 July 2009
Sites	1 location across Romania

Drugs / interventions tested

• Nebilet — full drug profile →
• Corvitol — full drug profile →

Conditions studied

• Primary Arterial Hypertension — all drugs for Primary Arterial Hypertension →

Sponsor

Berlin-Chemie Menarini — full company profile →

Who can join

18 and older, any sex, with Primary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes of: longitudinal myocardial velocities at rest (assessed by TDE), systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest), NT-proBNP
  Time frame: 6 months

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reversal of subclinical left ventricular dysfunction by antihypertensive treatment: a prospective trial of nebivolol against metoprolol.
   Vinereanu D, Gherghinescu C, Ciobanu AO, Magda S, et al · · 2011 · cited 14× · PMID 21297499 · DOI 10.1097/hjh.0b013e3283442f37