A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure
NCT00739193 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2017-09-11
Summary
The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.
Conditions
- Blood Pressure
Interventions
- DRUG
-
amiodarone
Sponsors & Collaborators
-
Prism Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
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