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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

HEP-40 chitosan

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, LDL-cholesterol, chitosan, HEP-40

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

JSS Medical Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HEP 400mg TID

HEP 800mg BID

HEP 800mg TID

HEP 2400mg QD

Placebo

Arm Description

HEP-40 400 mg three times a day

HEP-40 800 mg twice a day

HEP-40 800 mg three times a day

HEP-40 2400 mg once a day

Placebo, three times a day

Outcomes

Primary Outcome Measures

Percent change in serum LDL-C between the baseline and 4-week visit compared to placebo.

Secondary Outcome Measures

Percent change in serum LDL-C from baseline to 8- and 12-weeks of treatment compared to placebo

Percent change in serum total cholesterol from baseline to 12 weeks of treatment compared to placebo

Percent change in serum HDL-C from baseline to 12 weeks of treatment compared to placebo

Percent change in serum triglycerides from baseline to 12 weeks of treatment compared to placebo

Safety and tolerability over the 12-week active treatment period, as determined by treatment-emergent adverse events.

Full Information

NCT ID

NCT00454831

First Posted

March 30, 2007

Last Updated

November 14, 2007

Sponsor

DNP Canada

Collaborators

JSS Medical Research Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00454831

Brief Title

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

Acronym

HEP-40

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

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

DNP Canada

Collaborators

JSS Medical Research Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Hypercholesterolemia, LDL-cholesterol, chitosan, HEP-40

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HEP 400mg TID

Arm Type

Active Comparator

Arm Description

HEP-40 400 mg three times a day

Arm Title

HEP 800mg BID

Arm Type

Active Comparator

Arm Description

HEP-40 800 mg twice a day

Arm Title

HEP 800mg TID

Arm Type

Active Comparator

Arm Description

HEP-40 800 mg three times a day

Arm Title

HEP 2400mg QD

Arm Type

Active Comparator

Arm Description

HEP-40 2400 mg once a day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, three times a day

Intervention Type

Device

Intervention Name(s)

HEP-40 chitosan

Other Intervention Name(s)

Libracol

Intervention Description

Enzymatically Hydrolyzed Polychitosamine-40 kDa

Primary Outcome Measure Information:

Title

Percent change in serum LDL-C between the baseline and 4-week visit compared to placebo.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Percent change in serum LDL-C from baseline to 8- and 12-weeks of treatment compared to placebo

Time Frame

12 weeks

Title

Percent change in serum total cholesterol from baseline to 12 weeks of treatment compared to placebo

Time Frame

12 weeks

Title

Percent change in serum HDL-C from baseline to 12 weeks of treatment compared to placebo

Time Frame

12 weeks

Title

Percent change in serum triglycerides from baseline to 12 weeks of treatment compared to placebo

Time Frame

12 weeks

Title

Safety and tolerability over the 12-week active treatment period, as determined by treatment-emergent adverse events.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques HF Lenis, MD

Organizational Affiliation

Recherche Invascor Inc

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John S Sampalis, PhD

Organizational Affiliation

JSS Medical Research Inc.

Official's Role

Study Director

Facility Information:

Facility Name

JSS Medical Research Inc.

City

Westmount

State/Province

Quebec

ZIP/Postal Code

H3Z 1R7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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