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NCT00739193 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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

No results posted yet for this study

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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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 NCT00739193 on ClinicalTrials.gov