Trial Outcomes & Findings for Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia (NCT NCT00746811)
NCT ID: NCT00746811
Last Updated: 2024-05-31
Results Overview
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.
COMPLETED
PHASE4
32 participants
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).
2024-05-31
Participant Flow
Recruitment was conducted using the research clinic database and print advertisements.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
16
|
16
|
|
First Intervention (6 Weeks)
COMPLETED
|
15
|
16
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
15
|
16
|
|
Second Intervention (6 Weeks)
COMPLETED
|
15
|
16
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention (6 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
P-OM3 First, Then Placebo
n=15 Participants
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
|
Placebo First, Then P-OM3
n=16 Participants
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
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Body mass index
|
27.4 kg/m2
STANDARD_DEVIATION 0.91 • n=5 Participants
|
27.1 kg/m2
STANDARD_DEVIATION 0.85 • n=7 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 0.61 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
P-OM3
n=31 Participants
P-OM3 for six weeks
P-OM3: 4 grams/day - 4 one gram capsules
|
Placebo
n=31 Participants
Placebo for six weeks
Placebo: 4 grams/day - 4 one gram capsules
|
|---|---|---|
|
Percent Change From Baseline in LDL-C During Each Treatment
|
3.4 Percent change from baseline
Standard Error 1.8
|
-0.7 Percent change from baseline
Standard Error 1.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
P-OM3
n=31 Participants
P-OM3 for six weeks
P-OM3: 4 grams/day - 4 one gram capsules
|
Placebo
n=31 Participants
Placebo for six weeks
Placebo: 4 grams/day - 4 one gram capsules
|
|---|---|---|
|
Percent Changes in Other Lipid and Biomarker Levels
VLDL-C
|
-16.7 Percent change from baseline
Standard Error 3.0
|
2.0 Percent change from baseline
Standard Error 2.4
|
|
Percent Changes in Other Lipid and Biomarker Levels
TC
|
0.5 Percent change from baseline
Standard Error 1.1
|
-0.7 Percent change from baseline
Standard Error 1.2
|
|
Percent Changes in Other Lipid and Biomarker Levels
HDL-C
|
1.5 Percent change from baseline
Standard Error 1.4
|
-1.7 Percent change from baseline
Standard Error 1.2
|
|
Percent Changes in Other Lipid and Biomarker Levels
Non-HDL-C
|
0.3 Percent change from baseline
Standard Error 1.6
|
-0.4 Percent change from baseline
Standard Error 1.5
|
|
Percent Changes in Other Lipid and Biomarker Levels
TC/HDL-C
|
-0.6 Percent change from baseline
Standard Error 1.6
|
1.4 Percent change from baseline
Standard Error 1.3
|
|
Percent Changes in Other Lipid and Biomarker Levels
TG
|
-16.7 Percent change from baseline
Standard Error 3.0
|
2.0 Percent change from baseline
Standard Error 2.4
|
|
Percent Changes in Other Lipid and Biomarker Levels
Apo A1
|
-2.7 Percent change from baseline
Standard Error 1.2
|
-0.1 Percent change from baseline
Standard Error 1.2
|
|
Percent Changes in Other Lipid and Biomarker Levels
Apo B
|
-1.2 Percent change from baseline
Standard Error 1.5
|
-1.5 Percent change from baseline
Standard Error 1.5
|
Adverse Events
P-OM3
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Marshall, General Manager
Biofortis Research (formerly Provident)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place