Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
This study has been completed.
Sponsor:
Warner Chilcott
Information provided by:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00752596
First received: September 11, 2008
Last updated: March 22, 2010
Last verified: March 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 11, 2008 | ||||
| Last Updated Date | March 22, 2010 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
There was no outcome measure in this compassionate use [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00752596 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Congestive Heart Failure | ||||
| Intervention ICMJE | Drug: Azimilide 2HCl
One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated |
||||
| Study Arm (s) | Experimental: 1
1 tablet of 125 mg/day of azimilide 2HCl, oral
Intervention: Drug: Azimilide 2HCl |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00752596 | ||||
| Other Study ID Numbers ICMJE | 2005076 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Stephen R Marcello, MD, Procter and Gamble Pharmaceuticals | ||||
| Study Sponsor ICMJE | Warner Chilcott | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Warner Chilcott | ||||
| Verification Date | March 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||