Clinical trial NCT00454831: Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated Cholesterol
Official title: A 16 Week With 12 Week Active Treatment Multi-Center, Placebo-Controlled, Randomized Study Evaluating the Efficacy of HEP-40 Chitosan in Managing Moderate Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
LDL-cholesterol
chitosan
HEP-40
Lead sponsor: DNP Canada
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
First posted: 2007-04-02
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chitosan is a natural product that is produced commercially through the deacetylation of chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan has a lipid-lowering effect.

This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and effective in lowering LDL-cholesterol levels in patients with mild to moderately elevated cholesterol levels and who have not been previously treated with other lipid-lowering agents.

Detailed description: Chitosan is a natural product that is produced commercially through the deacetylation of chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan has a lipid-lowering effect by binding to fatty acids and cholesterol in the gastrointestinal tract and restricting their absorption.

This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and effective in lowering LDL-cholesterol levels in patients who have not been previously treated with lipid-lowering agents and who have cholesterol levels that are mild to moderately above the levels recommended by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines.

This is a multi-centre, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase where patients will be instructed to maintain a stable diet, patients will be randomized to one of the following study groups for a 12-week Active Treatment Phase:

* HEP-40 400 mg three times a day (400 mg TID)
* HEP-40 800 mg twice a day (800 mg BID)
* HEP-40 800 mg three times a day (800 mg TID)
* HEP-40 2400 mg once a day (2400 mg QD)
* Placebo, three times a day (placebo)

The primary objective is to evaluate the clinical benefit of administering HEP-40 chitosan at different doses and at different dosing regimens compared with placebo. Clinical benefit will be defined as the reduction in LDL-cholesterol after 4 weeks of active treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with borderline, mild or moderate hypercholesterolemia, defined as LDL-C levels between 2.0 mmol/L and 4.5 mmol/L;
* At low (≤10%) or moderate (11-19%) 10-year risk for cardiovascular disease according to the Framingham model;
* Treatment-naïve for any lipid-lowering medications including statins, other pharmaceuticals or nutraceuticals;
* Stable diet and willing to continue on the dietary regimen recommended by their physician (NCEP Step 1 Diet) for the duration of the study;
* Woman of child bearing potential must be practicing effective birth control for a period of at least one month prior to initiation of the study.

Exclusion Criteria:

* Any concomitant condition which in the opinion of the investigator would preclude the patient from successfully participating in the study;
* Pregnant or that are breast feeding;
* Participation in another clinical trial within 30 days from initiation of the study;
* Known cardiac disease including: congestive heart failure, cardiac arrhythmias, unstable angina, myocardial infarction within the last 6 months, or uncontrolled malignant hypertension;
* High risk of developing coronary artery disease;
* Any condition affecting a major organ system, such as liver or kidney disease or malignancy;
* Uncontrolled diabetes mellitus or newly diagnosed patients (within 3 months) or recent change in anti-diabetic pharmacotherapy within 3 months of screening;
* Evidence of active renal disease indicated by serum creatinine \> 2.0 mg/dL;
* Known HIV or Hepatitis B or C positive;
* Concurrent use of corticosteroids;
* Allergy or intolerance to crustaceans and/or seafood products.

Primary outcomes:
measure: Percent change in serum LDL-C between the baseline and 4-week visit compared to placebo.
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent change in serum LDL-C from baseline to 8- and 12-weeks of treatment compared to placebo
timeFrame: 12 weeks
measure: Percent change in serum total cholesterol from baseline to 12 weeks of treatment compared to placebo
timeFrame: 12 weeks
measure: Percent change in serum HDL-C from baseline to 12 weeks of treatment compared to placebo
timeFrame: 12 weeks
measure: Percent change in serum triglycerides from baseline to 12 weeks of treatment compared to placebo
timeFrame: 12 weeks
measure: Safety and tolerability over the 12-week active treatment period, as determined by treatment-emergent adverse events.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Westmount
country: Canada
facility: JSS Medical Research Inc.
state: Quebec
Study officials:
affiliation: Recherche Invascor Inc
name: Jacques HF Lenis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JSS Medical Research Inc.
name: John S Sampalis, PhD
role: STUDY_DIRECTOR
References: