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A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension

NCT01757808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-03

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of ranolazine in people with pulmonary arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies: ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or iloprost. The primary objective is:

* To estimate the effect of ranolazine administration on acute hemodynamics.
* To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after 12 weeks of therapy
* To assess changes in right ventricular function after 12 weeks of therapy.

Conditions

Interventions

DRUG

Ranolazine

ranolazine sustained release at a dose of 500mg for one month followed by a dose of 1000mg.

DRUG

Placebo

placebo at a dose of 500mg for one month followed by a dose of 1000mg.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Mardi Gomberg-Maitland, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757808 on ClinicalTrials.gov