CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Nebivololdrug
Likely dose
Nebivolol 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01961323
NCT01961323Phase 4Completed
CompareCT.gov

Effects of Nebivolol on Left Ventricular and Left Atrial Morphodynamics in Adults With Hypertension and Isolated Diastolic Dysfunction

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 11, 2013·Updated Nov 24, 2017

In Brief

A Phase 4 clinical trial evaluating Nebivolol for Hypertension and Left Ventricular Diastolic Dysfunction. Completed, enrolled 70 participants across 1 site.

Detailed Summary

To investigate whether treatment with Nebivolol in subjects with high blood pressure and abnormal filling of left ventricle (LVDD) improves exercise time by improving Left Ventricular deformation and filling.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Left Ventricular Diastolic Dysfunction
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 11, 2013
Enrollment StartMar 1, 2012
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 12.7 years ago

Interventions

Nebivololdrug

Doses will be titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.