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Sponsors and Collaborators: |
Provident Clinical Research GlaxoSmithKline |
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Information provided by: | Provident Clinical Research |
ClinicalTrials.gov Identifier: | NCT00746811 |
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.
Condition | Intervention | Phase |
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Primary Hypercholesterolemia |
Drug: P-OM3 Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 32 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment.
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Drug: P-OM3
4 grams/day - 4 one gram capsules
Drug: Placebo
4 grams/day - 4 one gram capsules
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2
Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment.
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Drug: P-OM3
4 grams/day - 4 one gram capsules
Drug: Placebo
4 grams/day - 4 one gram capsules
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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.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Provident Clinical Research | |
Addison, Illinois, United States, 60101 | |
United States, Indiana | |
Provident Clinical Research | |
Bloomington, Indiana, United States, 47403 |
Study Director: | Kevin C. Maki, PhD | Provident Clinical Research |
Responsible Party: | Provident Clinical Research ( Kevin C. Maki, PhD, Chief Science Officer ) |
Study ID Numbers: | PRV-08007 |
Study First Received: | September 2, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00746811 |
Health Authority: | United States: Institutional Review Board |
cholesterol hypercholesterolemia omega 3 |
Metabolic Diseases Hyperlipidemias Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |