drugset / Trial / NCT02133352

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

NCT02133352

Phase 4 Completed 10 enrolled Boston University Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-07
Primary completion
2013-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranolazine Small molecule 500 mg
Subject Ranolazine Small molecule 1000 mg