At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 32 enrolled
Drug / intervention
Definitydrug
Likely dose
Not stated in 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.
A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY® on Pulmonary Artery Hemodynamics in Patients With Normal and Increased Pulmonary Artery Pressure
In Brief
A Phase 4 clinical trial evaluating Definity for Pulmonary Heart Disease. Completed, enrolled 32 participants across 8 sites.
Detailed Summary
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Heart Disease
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartJul 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedJun 11, 2009
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.1 years ago
Interventions
Definitydrug
one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight