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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00752596
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : February 1, 2017
Information provided by:
Forest Laboratories

September 11, 2008
September 15, 2008
February 1, 2017
September 2005
July 2006   (Final data collection date for primary outcome measure)
There was no outcome measure in this compassionate use
Same as current
Complete list of historical versions of study NCT00752596 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Phase 2
Intervention Model: Single Group Assignment
Masking: None (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.
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.
Sexes Eligible for Study: Male
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Stephen R Marcello, MD, Procter and Gamble Pharmaceuticals
Forest Laboratories
Not Provided
Study Director: Stephen R Marcello, MD Procter and Gamble
Forest Laboratories
January 2017

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