Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated Cholesterol

This study has been completed.
Sponsor:
Collaborator:
JSS Medical Research Inc.
Information provided by:
DNP Canada
ClinicalTrials.gov Identifier:
NCT00454831
First received: March 30, 2007
Last updated: November 14, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Device: HEP-40 chitosan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DNP Canada:

Primary Outcome Measures:
  • Percent change in serum LDL-C between the baseline and 4-week visit compared to placebo. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Percent change in serum LDL-C from baseline to 8- and 12-weeks of treatment compared to placebo [ Time Frame: 12 weeks ]
  • Percent change in serum total cholesterol from baseline to 12 weeks of treatment compared to placebo [ Time Frame: 12 weeks ]
  • Percent change in serum HDL-C from baseline to 12 weeks of treatment compared to placebo [ Time Frame: 12 weeks ]
  • Percent change in serum triglycerides from baseline to 12 weeks of treatment compared to placebo [ Time Frame: 12 weeks ]
  • Safety and tolerability over the 12-week active treatment period, as determined by treatment-emergent adverse events. [ Time Frame: 12 weeks ]

Enrollment: 207
Study Start Date: February 2006
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: HEP 400mg TID
HEP-40 400 mg three times a day
Device: HEP-40 chitosan
Enzymatically Hydrolyzed Polychitosamine-40 kDa
Other Name: Libracol
Active Comparator: HEP 800mg BID
HEP-40 800 mg twice a day
Device: HEP-40 chitosan
Enzymatically Hydrolyzed Polychitosamine-40 kDa
Other Name: Libracol
Active Comparator: HEP 800mg TID
HEP-40 800 mg three times a day
Device: HEP-40 chitosan
Enzymatically Hydrolyzed Polychitosamine-40 kDa
Other Name: Libracol
Active Comparator: HEP 2400mg QD
HEP-40 2400 mg once a day
Device: HEP-40 chitosan
Enzymatically Hydrolyzed Polychitosamine-40 kDa
Other Name: Libracol
Placebo Comparator: Placebo
Placebo, three times a day
Device: HEP-40 chitosan
Enzymatically Hydrolyzed Polychitosamine-40 kDa
Other Name: Libracol

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454831

Locations
Canada, Quebec
JSS Medical Research Inc.
Westmount, Quebec, Canada, H3Z 1R7
Sponsors and Collaborators
DNP Canada
JSS Medical Research Inc.
Investigators
Principal Investigator: Jacques HF Lenis, MD Recherche Invascor Inc.
Study Director: John S Sampalis, PhD JSS Medical Research Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00454831     History of Changes
Other Study ID Numbers: 153-PTL-001
Study First Received: March 30, 2007
Last Updated: November 14, 2007
Health Authority: Canada: Health Canada

Keywords provided by DNP Canada:
Hypercholesterolemia
LDL-cholesterol
chitosan
HEP-40

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014