Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454831
Status:
COMPLETED
Last Update Posted:
2007-11-16
First Post:
2007-03-30
Brief Title:
Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated Cholesterol
Sponsor:
DNP Canada
Organization:
DNP Canada
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEP-40
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None