Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255216
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2005-11-16
Brief Title:
Policosanol for the Treatment of Hypercholesterolemia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Policosanol for the Treatment of Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2005-10
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:
None
Brief Summary:
Policosanol a compound derived from sugar cane wax and available in health food stores across the United States is a popular non-prescription product for treating hypercholesterolemia Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba
This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200 The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients The primary outcome measurements will be the percentage change in LDL-C Secondary outcomes will include changes in total cholesterol HDL-C triglycerides C-reactive protein and lipoprotein sub-particles This will be the first known randomized clinical trial of policosanol in North America
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health NIH
Specific Aim To independently corroborate the lipid lowering effects of policosanol in a small pilot study
This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200 The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients The primary outcome measurements will be the percentage change in LDL-C Secondary outcomes will include changes in total cholesterol HDL-C triglycerides C-reactive protein and lipoprotein sub-particles This will be the first known randomized clinical trial of policosanol in North America
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health NIH
Specific Aim To independently corroborate the lipid lowering effects of policosanol in a small pilot study
Detailed Description:
Policosanol a compound derived from sugar cane wax and available in health food stores across the United States is a popular non-prescription product for treating hypercholesterolemia Policosanol has been used in Cuba since 1991 to treat high cholesterol Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba According to the Cuban data policosanol can lower total cholesterol lower low-density lipoprotein cholesterol LDL-C and raise high-density lipoprotein cholesterol HDL-C Based on post-marketing surveys this drug appears to be devoid of any biochemical hematological or clinical adverse effects
Confirmation of this data on policosanol by scientifically rigorous experiments and trials in this country would provide a safe and effective therapeutic option for the treatment of hypercholesterolemia Consequently policosanol has the potential to become a valuable tool in the fight against coronary heart disease - a major cause of mortality in the United States
This pilot study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200 The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients The primary outcome measurements will be the percentage change in LDL-C Secondary outcomes will include changes in total cholesterol HDL-C triglycerides C-reactive protein and lipoprotein sub-particles This will be the first known randomized clinical trial of policosanol in North America
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health NIH Future studies could include an assessment of the effects of policosanol on other markers for coronary heart disease and potential use in combination with current lipid medications The overall goal is to perform a large multi-center clinical outcome trial to establish the precise clinical benefits of policosanol
Summary Demonstration of the lipid-lowering ability of policosanol is an initial step in providing a safe cost-effective therapy for hypercholesterolemia thereby advancing the treatment and prevention of cardiovascular disease in this country
Specific Aim To independently corroborate the lipid lowering effects of policosanol in a small pilot study
Hypotheses After 8 weeks of therapy policosanol 40 mgday will
1 Produce a statistically significant reduction in LDL-C compared to placebo
2 Provide a statistically significant reduction in LDL particle number and C-reactive protein
Confirmation of this data on policosanol by scientifically rigorous experiments and trials in this country would provide a safe and effective therapeutic option for the treatment of hypercholesterolemia Consequently policosanol has the potential to become a valuable tool in the fight against coronary heart disease - a major cause of mortality in the United States
This pilot study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200 The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients The primary outcome measurements will be the percentage change in LDL-C Secondary outcomes will include changes in total cholesterol HDL-C triglycerides C-reactive protein and lipoprotein sub-particles This will be the first known randomized clinical trial of policosanol in North America
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health NIH Future studies could include an assessment of the effects of policosanol on other markers for coronary heart disease and potential use in combination with current lipid medications The overall goal is to perform a large multi-center clinical outcome trial to establish the precise clinical benefits of policosanol
Summary Demonstration of the lipid-lowering ability of policosanol is an initial step in providing a safe cost-effective therapy for hypercholesterolemia thereby advancing the treatment and prevention of cardiovascular disease in this country
Specific Aim To independently corroborate the lipid lowering effects of policosanol in a small pilot study
Hypotheses After 8 weeks of therapy policosanol 40 mgday will
1 Produce a statistically significant reduction in LDL-C compared to placebo
2 Provide a statistically significant reduction in LDL particle number and C-reactive protein
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