A Phase 4 interventional study of P-OM3 and Placebo in Primary Hypercholesterolemia, sponsored by Provident Clinical Research. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Provident Clinical Research · Phase 4, Interventional, and Treatment
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 32 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Provident Clinical Research is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.
Drug: P-OM3 · Drug: Placebo
Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.
Drug: P-OM3 · Drug: Placebo
4 grams/day - 4 one gram capsules
Also known as: Lovaza
4 grams/day - 4 one gram capsules
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.
Time frame: 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).
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.
Time frame: 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).
Recruitment was conducted using the research clinic database and print advertisements.
| Milestone | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 |
|---|---|---|
| Started | 16 | 16 |
| Completed | 15 | 16 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Milestone | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 |
|---|---|---|
| Started | 15 | 16 |
| Completed | 15 | 16 |
| Not completed | 0 | 0 |
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.
| Percent change from baseline | P-OM3 | Placebo |
|---|---|---|
| Percent Change From Baseline in LDL-C During Each Treatment | 3.4 ± 1.8 | -0.7 ± 1.6 |
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.
| Percent change from baseline | P-OM3 | Placebo |
|---|---|---|
| TC | 0.5 ± 1.1 | -0.7 ± 1.2 |
| VLDL-C | -16.7 ± 3.0 | 2.0 ± 2.4 |
| HDL-C | 1.5 ± 1.4 | -1.7 ± 1.2 |
| Non-HDL-C | 0.3 ± 1.6 | -0.4 ± 1.5 |
| TC/HDL-C | -0.6 ± 1.6 | 1.4 ± 1.3 |
| TG | -16.7 ± 3.0 | 2.0 ± 2.4 |
| Apo A1 | -2.7 ± 1.2 | -0.1 ± 1.2 |
| Apo B | -1.2 ± 1.5 | -1.5 ± 1.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| P-OM3 | — | 0/16 (0%) | 0/16 (0%) |
| Placebo | — | 0/16 (0%) | 0/16 (0%) |
Baseline/adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product; n=31).
| Age, Categorical(Participants) | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 16 | 31 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| Mean | 57.3 ± 2.1 | 51.2 ± 2.9 | 54.2 ± 1.9 |
| Sex: Female, Male(Participants) | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| Female | 8 | 11 | 19 |
| Male | 7 | 5 | 12 |
| Ethnicity (NIH/OMB)(Participants) | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 15 | 16 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| United States | 15 | 16 | 31 |
| Body mass index(kg/m2) | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| Mean | 27.4 ± 0.91 | 27.1 ± 0.85 | 27.3 ± 0.61 |
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