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

NCT00454831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2007-11-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

HEP-40 chitosan

Enzymatically Hydrolyzed Polychitosamine-40 kDa

Sponsors & Collaborators

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • DNP Canada

    lead INDUSTRY

Principal Investigators

  • Jacques HF Lenis, MD · Recherche Invascor Inc

  • John S Sampalis, PhD · JSS Medical Research Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Completion
2007-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454831 on ClinicalTrials.gov