Status:
COMPLETED
Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated Cholesterol
Lead Sponsor:
DNP Canada
Collaborating Sponsors:
JSS Medical Research Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-lower...
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-lower...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00454831
Start Date
February 1 2006
End Date
September 1 2007
Last Update
November 16 2007
Active Locations (1)
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1
JSS Medical Research Inc.
Westmount, Quebec, Canada, H3Z 1R7