drugset / Trial / NCT00942487
Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol
RandomizedParallel-groupSingle-blindTreatment
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)
Timeline
- Start
- 2005-04
- Primary completion
- 2008-12
- Completion
- 2009-07
Publications
- Vinereanu D, Madler CF, Gherghinescu C, Ciobanu AO, Fraser AG. Cumulative impact of cardiovascular risk factors on regional left ventricular function and reserve: progressive long-axis dysfunction with compensatory radial changes. Echocardiography. 2011 Sep;28(8):813-20. doi: 10.1111/j.1540-8175.2011.01456.x. Epub 2011 Aug 9.
- Vinereanu D, Gherghinescu C, Ciobanu AO, Magda S, Niculescu N, Dulgheru R, Dragoi R, Lautaru A, Cinteza M, Fraser AG. Reversal of subclinical left ventricular dysfunction by antihypertensive treatment: a prospective trial of nebivolol against metoprolol. J Hypertens. 2011 Apr;29(4):809-17. doi: 10.1097/HJH.0b013e3283442f37.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metoprolol | Other / unclassified | 50 mg | Oral |
| Subject | Nebivolol | Other / unclassified | 5 mg | Oral |