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

NCT02582424 | Completed

• 1 other identifier: PDT-0101
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• lowering serum TG levels

  more effective than placebo at lowering serum TG levels

  8 weeks

Secondary Outcomes (1)

• lower serum LDL levels

  8 weeks

Study Arms (2)

PDL-0101

EXPERIMENTAL

EPA +astaxanthin

Other: PD-L0101

placebo

PLACEBO COMPARATOR

olive oil

Other: placebo

Interventions

PD-L0101 OTHER

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

PDL-0101

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 26, 2016

Record last verified: 2015-10