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This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.
This will be an 8 week, multicenter, randomized, double blind, placebo controlled trial. The screening visit will be divided into two parts, a "pre-screen" in-clinic rapid lipid test (Cholestech) followed by a full screening blood draw to be sent to the central reference laboratory (CRL) for subjects meeting the Cholestech inclusion values for TG and LDL (see inclusion criteria below) on the pre-screen test. Subjects who do not meet the pre-screen criteria will be discharged from further participation in the study. Subjects must have pre-screen lipid values of LDL >/=70 mg/dl and triglyceride (TG) >/=180 and </=499. Subjects who meet these Cholestech criteria will have blood drawn for central reference laboratory (CRL) screening testing. For randomization, 80% of the subjects must have TG>/=200 mg/dl to proceed to the next screening step while up to 20% will be allowed to proceed to the next screening step with TG=150-199 mg/dl as long as the LDL is>/=70 mg/dl. Subjects who meet the CRL pre-screen lipid inclusion criteria will return 2-14 days later for the remainder of the full screening procedures. Subjects who meet all screening criteria will be randomized at this visit. Thus, the prescreening and screening-1 visits will occur at the same time and the screening 2 visit will also be the baseline visit. BMI will be calculated but is not a criterion for participation.
Subjects who meet all inclusion and exclusion requirements at the screening 2/baseline visit will be randomized to receive one of the two (2) study products. Randomization will proceed in groups of 5 with 4 subjects having TG between 200-499 mg/dl before randomizing a subject with TG between 150-199 mg/dl. Subjects will return for evaluation 4 and 8 weeks after the baseline visit at which times adverse events (AEs) will be recorded, blood lipid studies will be done and subjects will complete a VAS for product tolerability. Laboratory studies will be drawn after subjects have been sitting for at least 5 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDL-0101 | Experimental | EPA +astaxanthin |
|
| placebo | Placebo Comparator | olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-L0101 | Other | 92% EPA+6 mg ATX+50 mg TCT GG BID |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| lowering serum TG levels | more effective than placebo at lowering serum TG levels | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| lower serum LDL levels | lower serum LDL levels | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Udani, MD | Medicus Research 18250 Roscoe Blvd. Northridge CA 91325 | Principal Investigator |
| Andrea Lawless, MD | Provident Clinical Research 211 E Lake St. Addison IL 60101 | Principal Investigator |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other |
placebo |
|