LIP-01 in Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966225
• Other study ID #: LIP-01-2009-1
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2009
• Last updated: January 26, 2012
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Afexa Life Sciences Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• LIP-01
comparison of different dosages of natural health product

Locations

Country	Name	City	State
Canada	The Northern Alberta Clinical Trials and Research Centre	Edmonton	Alberta
United States	Medicus Research, LLC	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
Afexa Life Sciences Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine a safe and tolerable dose of LIP-01		12 weeks	Yes