A Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d P-OM3 on LDL-C and Other Aspects of the Fasting Lipid Profile in Subjects With Primary Hypercholesterolemia
| City: |
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Addison |
| State: |
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Illinois |
| Zip Code: |
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60101 |
| Conditions: |
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Primary Hypercholesterolemia |
| Purpose: |
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The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with
placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary
hypercholesterolemia.
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| Study Summary: |
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This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2
(Week 0), subjects meeting all entry criteria will be randomized to one of two treatment
sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they
did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.
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| Criteria: |
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Inclusion Criteria:
- Men and women, ages 18-79 inclusive
- Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline
high to very high range
- Fasting, untreated triglyceride (TG)level in the normal range
- Provide written informed consent and authorization for protected health information
Exclusion Criteria:
- CHD or CHD risk equivalent
- Pregnancy
- Use of lipid altering medications which cannot be stopped
- Body mass index over 45 kg per square meter
- Allergy or sensitivity to omega-3 fatty acids
- Certain muscle, liver, kidney, lung or gastrointestinal conditions
- Poorly controlled hypertension
- Certain medications
- Active cancers treated within prior 2 years (except non-melanoma skin cancer)
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| NCT ID: |
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NCT00746811 |
| Primary Contact: |
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Study Director
Kevin C. Maki, PhD
Provident Clinical Research
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| Backup Contact: |
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N/A |
| Location Contact: |
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Addison, Illinois 60101
United States
John Marshall, RN, BSN
Phone: 630-617-2000
Email: research@providentcrc.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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