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Sponsors and Collaborators: |
Invitrox Reliant Pharmaceuticals |
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Information provided by: | Invitrox |
ClinicalTrials.gov Identifier: | NCT00515541 |
This study is to determine the effects of Lovaza in platelet function studies
Condition | Intervention | Phase |
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Cardiovascular Disease Bleeding |
Drug: Lovaza |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of the Omega n3 Fatty on Human Platelet Function |
Estimated Enrollment: | 40 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
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A: Active Comparator
Patient is not on Aspirin, Clopidogrel, or Warfarin and is taking escalating doses of study drug.
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Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
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B: Active Comparator
Patient is on regular dose of Aspirin ( < or = 325mg). Patient is not taking Clopidogrel or Warfarin and is taking the escalating doses of Lovaza
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Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
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C: Active Comparator
Patient is taking regularly 75mg of clopidogrel daily and Aspirin (< or = 325mg) and not taking Warfarin and is taking the escalating doses of Lovaza
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Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
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D: Active Comparator
Patient is regularly taking Warfarin daily and is not taking Aspirin or Clopidogrel and is taking the escalating doses of Lovaza
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Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer A Garbarino, MA | 919-843-5212 ext XXXX | jennifer_garbarino@med.unc.edu |
Contact: Carl Schuler, RN | 919-843-4597 ext XXXX | carl_schuler@med.unc.edu |
United States, North Carolina | |
The University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Jennifer A Garbarino, MA 919-843-5215 ext XXXX jennifer_garbarino@med.unc.edu | |
Contact: Carl Schuler, RN 919-843-4597 ext XXXX carl_schuler@med.unc.edu | |
Principal Investigator: Mauricio Cohen, MD |
Principal Investigator: | Mauricio Cohen, MD | The University of North Carolina at Chapel Hill |
Study ID Numbers: | 07-1068 |
Study First Received: | August 10, 2007 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00515541 |
Health Authority: | United States: Food and Drug Administration |
Platelet Cardiovascular Lipid Fish Oil Omega 3 DHA |
EPA Bleeding Clotting platelet function Lipid profile Weight and Bleeding risk |
Body Weight Hemorrhage |
Cardiovascular Diseases |