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NCT02133352 · ClinicalTrials.gov registry record · Phase 4
Study of Ranolazine in the Treatment of Pulmonary Hypertension Associated With Diastolic Left Ventricular Dysfunction
A Phase 4 study of Pulmonary Hypertension and Diastolic Left Ventricular Dysfunction, sponsored by Boston University.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02133352: Completed Phase 4 study of Pulmonary Hypertension and Diastolic Left Ventricular Dysfunction, sponsored by Boston University.
NCT02133352 is a Phase 4 study of Pulmonary Hypertension and Diastolic Left Ventricular Dysfunction that has completed, run by Boston University. The registered enrollment target is 10 participants, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02133352, a Phase 4 study of Pulmonary Hypertension and Diastolic Left Ventricular Dysfunction, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assess the percent change in mPAP, PAOP and pulmonary vascular resistance (PVR) by RHC. Additional RHC completed at optional follow up for patients remaining on ranolazine upon completion of 180 day period.
Conditions Studied
Interventions
- DRUG Ranolazine
Study Locations (1)
Massachusetts
- Boston University Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT02133352 record still lists
NCT02133352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Pulmonary Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Ranolazine is the first listed.
NCT02133352 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02133352 about?
NCT02133352 is a clinical study titled "Study of Ranolazine in the Treatment of Pulmonary Hypertension Associated With Diastolic Left Ventricular Dysfunction". 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 ...
What is the current status of trial NCT02133352?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2011-07. Estimated completion is 2014-05.
What conditions does trial NCT02133352 study?
This clinical trial studies the following conditions: Pulmonary Hypertension, Diastolic Left Ventricular Dysfunction.
What interventions are being tested in trial NCT02133352?
The interventions under investigation include: Ranolazine (DRUG).
Who is sponsoring clinical trial NCT02133352?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02133352 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02133352's enrollment target sits among peer trials
10 67th of 72 higher than 4 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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