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

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

PD-L0101

placebo

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Either gender, in general good health, between 25-85 years old
Serum TG 150-495 mg/dl at screening
Serum LDL >/= 70 mg/dl at screening
Not using any other product including drugs, medical foods, neutraceuticals or dietary supplements for control of serum lipids
Consistent dietary habits
Women of child bearing potential must use an accepted method of birth control
Able to read and understand study documents including the Subject Informed Consent Document (Spanish language translation available, if needed)

Exclusion Criteria:

serum TG <150 or >495 mg/dl at screening visit
serum LDL<50 mg/dl at screening visit
use of any other serum lipid modifying agent (see section 6.0) within 4 weeks of screening visit
history of any intestinal disease that might interfere with absorption
history of pancreatitis, inflammatory colitis or prior cholecystectomy
any active malignancy or history of malignancy, except basal cell carcinoma or cervical carcinoma in situ curatively treated, within 3 years of the screening visit
screening AST, ALT, alkaline phosphatase, bilirubin >1.3 times the upper limit of normal for the reference laboratory
serum creatinine >2.0
uncontrolled diabetes mellitus (glycosylated Hgb >9)
diabetes mellitus not on stable therapy for at least 2 months
uncontrolled hypertension (DBP >100, SPB >160)
unstable angina, congestive heart failure or other uncontrolled cardiac disease
pregnant or lactating women
known history of allergies to O-3 fatty acids, carotenoids, vitamin E or fish products
history of substance abuse or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
Regular consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol consists of 12 oz. of beer, 6 oz. of wine or 2 oz of hard spirits.
any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study
participation in another clinical trial within 30 days or 6 half lives of the study agent, whichever is longer, of the screening visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PDL-0101

placebo

Arm Description

EPA +astaxanthin

olive oil

Outcomes

Primary Outcome Measures

lowering serum TG levels

more effective than placebo at lowering serum TG levels

Secondary Outcome Measures

lower serum LDL levels

Full Information

NCT ID

NCT02582424

First Posted

October 19, 2015

Last Updated

January 25, 2016

Sponsor

Primus Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02582424

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Primus Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PDL-0101

Arm Type

Experimental

Arm Description

EPA +astaxanthin

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

olive oil

Intervention Type

Other

Intervention Name(s)

PD-L0101

Intervention Description

92% EPA+6 mg ATX+50 mg TCT GG BID

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

lowering serum TG levels

Description

more effective than placebo at lowering serum TG levels

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

lower serum LDL levels

Description

lower serum LDL levels

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Either gender, in general good health, between 25-85 years old Serum TG 150-495 mg/dl at screening Serum LDL >/= 70 mg/dl at screening Not using any other product including drugs, medical foods, neutraceuticals or dietary supplements for control of serum lipids Consistent dietary habits Women of child bearing potential must use an accepted method of birth control Able to read and understand study documents including the Subject Informed Consent Document (Spanish language translation available, if needed) Exclusion Criteria: serum TG <150 or >495 mg/dl at screening visit serum LDL<50 mg/dl at screening visit use of any other serum lipid modifying agent (see section 6.0) within 4 weeks of screening visit history of any intestinal disease that might interfere with absorption history of pancreatitis, inflammatory colitis or prior cholecystectomy any active malignancy or history of malignancy, except basal cell carcinoma or cervical carcinoma in situ curatively treated, within 3 years of the screening visit screening AST, ALT, alkaline phosphatase, bilirubin >1.3 times the upper limit of normal for the reference laboratory serum creatinine >2.0 uncontrolled diabetes mellitus (glycosylated Hgb >9) diabetes mellitus not on stable therapy for at least 2 months uncontrolled hypertension (DBP >100, SPB >160) unstable angina, congestive heart failure or other uncontrolled cardiac disease pregnant or lactating women known history of allergies to O-3 fatty acids, carotenoids, vitamin E or fish products history of substance abuse or any psychiatric condition that may impair the subject's ability to comply with the study requirements. Regular consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol consists of 12 oz. of beer, 6 oz. of wine or 2 oz of hard spirits. any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study participation in another clinical trial within 30 days or 6 half lives of the study agent, whichever is longer, of the screening visit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jay Udani, MD

Organizational Affiliation

Medicus Research 18250 Roscoe Blvd. Northridge CA 91325

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrea Lawless, MD

Organizational Affiliation

Provident Clinical Research 211 E Lake St. Addison IL 60101

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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