A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP (MiniMetrxics)
This study has been completed.
Sponsor:
Cardiometabolics
Information provided by:
Cardiometabolics
ClinicalTrials.gov Identifier:
NCT00500929
First received: July 12, 2007
Last updated: March 23, 2009
Last verified: March 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 12, 2007 | ||||
| Last Updated Date | March 23, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
ICU Time [ Time Frame: 30 to 45 days post-surgery ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00500929 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 | A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP | ||||
| Official Title ICMJE | Mini-Metrxics: A Single-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Clinical Trial of CMI X-11S in Higher Risk Geriatric Patients Undergoing Open-Heart Surgical Procedures (OHSP) | ||||
| Brief Summary | To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Heart Disease | ||||
| Intervention ICMJE | Drug: CMI X-11S | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 70 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00500929 | ||||
| Other Study ID Numbers ICMJE | CMI X-11S-G-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Cardiometabolics | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cardiometabolics | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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