NCT00752596

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

September 11, 2008

Last Update Submit

January 31, 2017

Conditions

Congestive Heart Failure

Keywords

patientswith ICD

Outcome Measures

Primary Outcomes (1)

  • There was no outcome measure in this compassionate use

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Azimilide 2HCl

Interventions

Azimilide 2HClDRUG

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

1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Scottsdale, Arizona, 85251, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Stephen R Marcello, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 15, 2008

Study Start

September 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)