Clinical trial NCT00966225: LIP-01 in Hypercholesterolemia
Official title: An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Afexa Life Sciences Inc
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine a safe and tolerable dose of LIP-01


Eligibility criteria: Inclusion Criteria:

* Age between 18-75 years
* Plasma total-cholesterol \>5.2 mmol/L (\> 200 mg/dL)
* Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
* Willingness and ability to sign written informed consent
* Women of child bearing capacity who agree to use an acceptable form of birth control during the trial \[i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation\]

Exclusion Criteria:

* Plasma triglycerides \> 4.0 mmol/L (\> 354 mg/dL)
* Plasma LDL ≥ 5.0 mmol/L (≥ 195 mg/dL)
* Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris)
* Moderate/high risk of coronary artery/ cardiovascular disease
* Diabetes mellitus
* Uncorrected hypothyroidism
* Other significant metabolic endocrine disease
* Uncontrolled hypertension (\>160 systolic or \>100 diastolic)
* Active liver disease (ALT \>2x normal)
* Significant gastrointestinal disease
* Acute inflammatory disease
* Significant kidney disease (calculated by eGFR \<60 mL/min)
* Any other significant medical condition which, in the opinion of the investigator, could compromise patient safety or confound trial results
* Any significant/relevant surgery within the last year
* Use of lipid-lowering drugs
* Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid)
* Regular use of natural health products or dietary supplements known to affect lipid or lipoprotein levels (omega-3 fatty acids, green tea extracts, guggulipid, psyllium, plant sterols, policosanols). If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.
* Pregnant or lactating women
* Known allergy to any ingredient in the study product, including: Coptis chinensis, Ilex kudingcha, microcrystalline cellulose and magnesium stearate

Primary outcomes:
measure: To determine a safe and tolerable dose of LIP-01
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Medicus Research, LLC
state: California
city: Edmonton
country: Canada
facility: The Northern Alberta Clinical Trials and Research Centre
state: Alberta
Study officials:
affiliation: University of Alberta
name: Richard Lewanczuk, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: