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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-OM3 then Placebo | Other | P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment. |
|
| Placebo then P-OM3 | Other | Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-OM3 | Drug | 4 grams/day - 4 one gram capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C During Each Treatment | The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. Baseline will be considered the average of values obtained at weeks -1 and 0. On-treatment values will be the average of values collected at weeks 5 and 6 for phase 1, and the average of values collected at weeks 11 and 12 for phase 2. | Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Changes in Other Lipid and Biomarker Levels | Percent changes from baseline in the levels of TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio and Apo AI and B. Baseline and on-treatment values for TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio will be calculated as described for LDL-C. Baseline values for Apo AI and B will include the average of values obtained at weeks -1 and 0. On-treatment values for Apo AI and B will be the average of values collected at weeks 6 and 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C. Maki, PhD | Provident Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident Clinical Research | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21297494 | Result | Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94. doi: 10.1097/FJC.0b013e318210fca5. |
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Recruitment was conducted using the research clinic database and print advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | P-OM3 First, Then Placebo | P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment. P-OM3: 4 grams/day - 4 one gram capsules Placebo: 4 grams/day - 4 one gram capsules |
| FG001 | Placebo First, Then P-OM3 | Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment. P-OM3: 4 grams/day - 4 one gram capsules Placebo: 4 grams/day - 4 one gram capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
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| Second Intervention (6 Weeks) |
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Baseline/adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product; n=31).
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| ID | Title | Description |
|---|---|---|
| BG000 | P-OM3 First, Then Placebo | P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment. P-OM3: 4 grams/day - 4 one gram capsules Placebo: 4 grams/day - 4 one gram capsules |
| BG001 | Placebo First, Then P-OM3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C During Each Treatment | The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. Baseline will be considered the average of values obtained at weeks -1 and 0. On-treatment values will be the average of values collected at weeks 5 and 6 for phase 1, and the average of values collected at weeks 11 and 12 for phase 2. | Posted | Mean | Standard Error | Percent change from baseline | Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | P-OM3 | P-OM3 for the first six weeks of treatment or POM-3 for the second 6 weeks of treatment, depending on group assignment. P-OM3: 4 grams/day - 4 one gram capsules |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Marshall, General Manager | Biofortis Research (formerly Provident) | 630-748-5339 | john.marshall@mxns.com |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Placebo | Drug | 4 grams/day - 4 one gram capsules |
|
| Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase). |
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Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment. P-OM3: 4 grams/day - 4 one gram capsules Placebo: 4 grams/day - 4 one gram capsules |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/m2 |
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Placebo for six weeks Placebo: 4 grams/day - 4 one gram capsules |
|
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| Secondary | Percent Changes in Other Lipid and Biomarker Levels | Percent changes from baseline in the levels of TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio and Apo AI and B. Baseline and on-treatment values for TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio will be calculated as described for LDL-C. Baseline values for Apo AI and B will include the average of values obtained at weeks -1 and 0. On-treatment values for Apo AI and B will be the average of values collected at weeks 6 and 12. | Posted | Mean | Standard Error | Percent change from baseline | Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase). |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Placebo | Placebo for the first six weeks of treatment or Placebo for the second 6 weeks of treatment, depending on group assignment. Placebo: 4 grams/day - 4 one gram capsules | 0 | 16 | 0 | 16 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| HDL-C |
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| Non-HDL-C |
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| TC/HDL-C |
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| TG |
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| Apo A1 |
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| Apo B |
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