CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Ranolazine +1 moredrug
Likely dose
Ranolazine 500mgfrom 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/NCT01839110
NCT01839110Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine on Outcomes in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Accompanied by a Comparative Study of Cellular Metabolism in Subjects With Pulmonary Hypertension With and Without Right Ventricular Dysfunction

University of Pennsylvania·interventional·Posted Apr 24, 2013·Updated Feb 5, 2019

In Brief

A Phase 4 clinical trial evaluating Ranolazine and Placebo for Pulmonary Hypertension. Completed, enrolled 22 participants across 3 sites.

Detailed Summary

This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF \<45%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesUnited States
CollaboratorsThe Cardiovascular Medical Research and Education Fund, Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2013
Enrollment StartJul 1, 2013
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.2 years ago

Interventions

Ranolazinedrug

Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.

Placebodrug

Placebo by mouth twice per day for a total of 26 weeks.