NCT02582424

Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study.

Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.

Detailed description

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
OTHER	PD-L0101	92% EPA+6 mg ATX+50 mg TCT GG BID
OTHER	placebo	placebo

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2015-10-21
• Last updated: 2016-01-26