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

This study has been completed.
Sponsor:
Information provided by:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00752596
First received: September 11, 2008
Last updated: March 22, 2010
Last verified: March 2010

September 11, 2008
March 22, 2010
September 2005
July 2006   (final data collection date for primary outcome measure)
There was no outcome measure in this compassionate use [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00752596 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Drug: Azimilide 2HCl
One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated
Experimental: 1
1 tablet of 125 mg/day of azimilide 2HCl, oral
Intervention: Drug: Azimilide 2HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy

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.
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00752596
2005076
No
Stephen R Marcello, MD, Procter and Gamble Pharmaceuticals
Warner Chilcott
Not Provided
Study Director: Stephen R Marcello, MD Procter and Gamble
Warner Chilcott
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP