Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient

NCT ID: NCT00752596

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-07-31

Brief Summary

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This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

1 tablet of 125 mg/day of azimilide 2HCl, oral

Group Type EXPERIMENTAL

Azimilide 2HCl

Intervention Type DRUG

One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated

Interventions

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Azimilide 2HCl

One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
* Is unwilling or unable to give or understand informed consent.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter and Gamble Pharmaceuticals

Principal Investigators

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Stephen R Marcello, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Research Site

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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2005076

Identifier Type: -

Identifier Source: org_study_id

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