HypercholesterolemiaPhase 2HEP-40NCT00454831

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

A Phase 2 study testing HEP-40 chitosan in people with Hypercholesterolemia, run by DNP Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia
What is being tested?: HEP-40 chitosan
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 1 siteCanada
Study dates: Feb 2006to Sep 2007
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

JSS Medical Research Inc.
Westmount, Quebec, H3Z 1R7

Other trials in Canada

About this study

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

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.

Read the detailed description

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.

Conditions: Hypercholesterolemia
Being tested: HEP-40 chitosan
Keywords: Hypercholesterolemia, LDL-cholesterol, chitosan, HEP-40
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HEP-40 chitosanDevice
Also called Libracol
Enzymatically Hydrolyzed Polychitosamine-40 kDa

Study groups in NCT00454831
Study group	Role	What they receive
HEP 400mg TID	Active comparator	HEP-40 400 mg three times a day Receives: Device: HEP-40 chitosan
HEP 800mg BID	Active comparator	HEP-40 800 mg twice a day Receives: Device: HEP-40 chitosan
HEP 800mg TID	Active comparator	HEP-40 800 mg three times a day Receives: Device: HEP-40 chitosan
HEP 2400mg QD	Active comparator	HEP-40 2400 mg once a day Receives: Device: HEP-40 chitosan
Placebo	Placebo comparator	Placebo, three times a day Receives: Device: HEP-40 chitosan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Sep 2007

First posted2 Apr 2007 (estimated)
Study startFeb 2006
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00454831
Sponsor's protocol ID: 153-PTL-001
Acronym: HEP-40
Status last verified: Nov 2007
First submitted: 30 Mar 2007
Last updated: 16 Nov 2007
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00454831
Acronym / sponsor ID: HEP-40 / 153-PTL-001
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia, LDL-cholesterol, chitosan, HEP-40
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: DNP CanadaIndustry (pharma, biotech, devices)
Collaborators: JSS Medical Research Inc.
Study start: Feb 2006
Study completion: Sep 2007 (actual)
First posted: 2 Apr 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
HEP 400mg TID	Active comparator	Device: HEP-40 chitosanHEP-40 400 mg three times a day
HEP 800mg BID	Active comparator	Device: HEP-40 chitosanHEP-40 800 mg twice a day
HEP 800mg TID	Active comparator	Device: HEP-40 chitosanHEP-40 800 mg three times a day
HEP 2400mg QD	Active comparator	Device: HEP-40 chitosanHEP-40 2400 mg once a day
Placebo	Placebo comparator	Device: HEP-40 chitosanPlacebo, three times a day

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HEP-40 chitosanAlso: LibracolEnzymatically Hydrolyzed Polychitosamine-40 kDa	Device	HEP 2400mg QD, HEP 400mg TID, HEP 800mg BID, HEP 800mg TID, Placebo

Primary outcome

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

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2007.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacques HF Lenis, MD principal investigator

Recherche Invascor Inc

John S Sampalis, PhD study director

JSS Medical Research Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HEP-40 chitosan in people with Hypercholesterolemia, run by DNP Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in serum LDL-C between the baseline and 4-week visit compared to placebo. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00454831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2007.