Primary Hypercholesterolemia
Conditions
Keywords
cholesterol, hypercholesterolemia, omega 3
Brief summary
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.
Detailed description
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.
Interventions
DRUGP-OM3
4 grams/day - 4 one gram capsules
DRUGPlacebo
4 grams/day - 4 one gram capsules
Sponsors
GlaxoSmithKline
Provident Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in LDL-C During Each Treatment | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes in Other Lipid and Biomarker Levels | 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 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted using the research clinic database and print advertisements.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (6 Weeks) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | P-OM3 First, Then Placebo | Placebo First, Then P-OM3 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Continuous | 57.3 years STANDARD_DEVIATION 2.1 | 51.2 years STANDARD_DEVIATION 2.9 | 54.2 years STANDARD_DEVIATION 1.9 |
| Body mass index | 27.4 kg/m2 STANDARD_DEVIATION 0.91 | 27.1 kg/m2 STANDARD_DEVIATION 0.85 | 27.3 kg/m2 STANDARD_DEVIATION 0.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 31 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P-OM3 | Percent Change From Baseline in LDL-C During Each Treatment | 3.4 Percent change from baseline | Standard Error 1.8 |
| Placebo | Percent Change From Baseline in LDL-C During Each Treatment | -0.7 Percent change from baseline | Standard Error 1.6 |
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.
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | TC | 0.5 Percent change from baseline | Standard Error 1.1 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | VLDL-C | -16.7 Percent change from baseline | Standard Error 3 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | HDL-C | 1.5 Percent change from baseline | Standard Error 1.4 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | Non-HDL-C | 0.3 Percent change from baseline | Standard Error 1.6 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | TC/HDL-C | -0.6 Percent change from baseline | Standard Error 1.6 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | TG | -16.7 Percent change from baseline | Standard Error 3 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | Apo A1 | -2.7 Percent change from baseline | Standard Error 1.2 |
| P-OM3 | Percent Changes in Other Lipid and Biomarker Levels | Apo B | -1.2 Percent change from baseline | Standard Error 1.5 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | Apo B | -1.5 Percent change from baseline | Standard Error 1.5 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | TC | -0.7 Percent change from baseline | Standard Error 1.2 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | TC/HDL-C | 1.4 Percent change from baseline | Standard Error 1.3 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | VLDL-C | 2.0 Percent change from baseline | Standard Error 2.4 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | Apo A1 | -0.1 Percent change from baseline | Standard Error 1.2 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | HDL-C | -1.7 Percent change from baseline | Standard Error 1.2 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | TG | 2.0 Percent change from baseline | Standard Error 2.4 |
| Placebo | Percent Changes in Other Lipid and Biomarker Levels | Non-HDL-C | -0.4 Percent change from baseline | Standard Error 1.5 |