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Cordarone

Phase 1FDA approved

Undisclosed | Small molecule | Other |Baxter International Inc.|Trials Updated: Sep 8, 2017

Cordarone development status

FDA approval on record Mar 13, 2009
Approval holderWyeth Pharms Inc
ApplicationNDA020377
Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Cordarone clinical trials

Cordarone · 1 trial · 1 indication

Phase 1 1
NCT00420953Relative Bioavailability of PM101 IV and Cordarone IVHealthy
COMPLETED- Analytics
PHASE1COMPLETED
Relative Bioavailability of PM101 IV and Cordarone IV
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative bioavailability and safety
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
CordaroneDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Be a healthy male or female 18 to 59 years of age, inclusive. Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial and must have a negative serum pregnancy test at screening and upon check-in to the study faci...

Countries:Canada
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Frequently asked questions about Cordarone

What is Cordarone?

Cordarone is a small molecule drug developed by Baxter International Inc. (ticker: BAX). It is in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. One Phase 1 trial of Cordarone has been completed.

Who makes Cordarone?

Cordarone is being developed by Baxter International Inc., which trades under the ticker symbol BAX. Baxter is the sponsor associated with the clinical development program for Cordarone.

What phase is Cordarone in?

Cordarone is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because the available information does not indicate regulatory approval, Cordarone should be considered investigational.

What clinical trials is Cordarone in?

Cordarone has been studied in one completed Phase 1 trial, NCT00420953, titled Relative Bioavailability of PM101 IV and Cordarone IV. The trial enrolled healthy volunteers age 18 and older of all sexes and was conducted in Canada. It used a randomized, double-blind design with an uncontrolled control type.