CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Ranolazinedrug
Likely dose
Ranolazine 500 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/NCT02133352
NCT02133352Phase 4Completed

Proof of Concept Study of Ranolazine in the Treatment of Pulmonary Hypertension Associated With Diastolic Left Ventricular Dysfunction

Boston University·interventional·Posted May 8, 2014·Updated May 17, 2017

In Brief

A Phase 4 clinical trial evaluating Ranolazine for Pulmonary Hypertension and Diastolic Left Ventricular Dysfunction. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This is a single center, open-label trial designed to assess the safety and efficacy of ranolazine (Ranexa) in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction. All patients will receive active drug. The study includes a screening period, 6 month treatment period and a follow up period. Eligible patients who provide informed consent and who meet all inclusion/exclusion criteria will be enrolled in this study. There is neither proven therapy for patients with diastolic dysfunction-associated pulmonary hypertension nor for patients with diastolic dysfunction alone. Ranolazine, an inhibitor of cardiac repolarization (sodium channels), could represent a new and effective treatment of this entity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2014
Enrollment StartJul 1, 2011
Primary CompletionMay 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.2 years ago

Interventions

Ranolazinedrug

Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated