A Study to Evaluate the Lipid Regulating Effects of TRIA-662
Tracking Information | |||||
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First Received Date ICMJE | September 23, 2008 | ||||
Last Updated Date | March 12, 2010 | ||||
Start Date ICMJE | September 2007 | ||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study [ Time Frame: Baseline to end of 12 weeks of active treatment ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00758303 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers [ Time Frame: From baseline to the end of 12 weeks of active treatment ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Lipid Regulating Effects of TRIA-662 | ||||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662 | ||||
Brief Summary | The purpose of this study is to determine the effectiveness and safety of TRIA-662 (also known as 1-MNA) in treating elevated triglyceride levels in patients not receiving lipid lowering treatment. This study will determine the effects of TRIA-662 on commonly measured blood fats that are known to be important in the prevention of vascular disease. |
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Detailed Description | This is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. Following a 6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) > 200 mg/dl (2.26 mmol/l) will be randomized to receive either placebo, 30 mg TRIA-662 or 90 mg TRIA-662 three times daily for twelve weeks. Lipid and ancillary exploratory parameters will be evaluated at screening, during the baseline period, upon randomisation and throughout the 12-week active treatment period. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hyperlipidemia | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* 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 | ||||
Enrollment ICMJE | 211 | ||||
Completion Date | December 2008 | ||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00758303 | ||||
Other Study ID Numbers ICMJE | Cortria-001 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Dr. Jean-Claude Tardif, Montreal Heart Institute | ||||
Study Sponsor ICMJE | Cortria Corporation | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Cortria Corporation | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |