Sitosterolemia Metabolism (STAIR7002)
This study is currently recruiting participants.
Verified April 2012 by University of Manitoba
Sponsor:
University of Manitoba
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01584206
First received: April 16, 2012
Last updated: April 23, 2012
Last verified: April 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 16, 2012 | ||||||||
| Last Updated Date | April 23, 2012 | ||||||||
| Start Date ICMJE | April 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01584206 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sitosterolemia Metabolism | ||||||||
| Official Title ICMJE | Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe | ||||||||
| Brief Summary | Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this study is to determine if ezetimibe improves whole body plant sterol and cholesterol homeostasis. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Sitosterolemia | ||||||||
| Intervention ICMJE | Drug: Ezetimibe
10mg ezetimibe/day, at least 4 months |
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| Study Arm (s) | Experimental: Ezetimibe
Compare on and off ezetimibe
Intervention: Drug: Ezetimibe |
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| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 8 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01584206 | ||||||||
| Other Study ID Numbers ICMJE | B2011:051 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Manitoba | ||||||||
| Study Sponsor ICMJE | University of Manitoba | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Manitoba | ||||||||
| Verification Date | April 2012 | ||||||||
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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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