Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00706849
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2008-06-26
Brief Title:
Efficacy and Safety Study of ISIS 301012 Mipomersen as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
Sponsor:
Kastle Therapeutics LLC
Organization:
Kastle Therapeutics LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Assess Efficacy and Safety of ISIS 301012 as Add-on Therapy in Heterozygous Familial Hypercholesterolemia Subjects With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2016-08
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:
RADICHOL II
Brief Summary:
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol LDL-C in patients with Heterozygous Familial Hypercholesterolemia HeFH and coronary artery disease CAD who are already on a stable dose of other lipid-lowering agents including maximally tolerated statin therapy
Detailed Description:
Familial hypercholesterolemia FH is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated LDL-C premature onset of atherosclerosis and development of xanthomata Patients with heterozygous familial hypercholesterolemia typically have total plasma cholesterol between 350 to 550 mgdL and disease onset in their third and fourth decade
Mipomersen ISIS 301012 is an antisense drug that reduces a protein in the liver cells called apolipoprotein B apo-B Apo-B plays a role in producing low density lipoprotein cholesterol the bad cholesterol and moving it from the liver to ones bloodstream High LDL-C is an independent risk factor for the development of coronary heart disease CHD or other diseases of blood vessels It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events
This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period with the exception of patients who enrolled in the open-label extension study Study 301012-CS6 NCT00694109 The treatment period spanned the time during which the study treatment was administered until the later of the primary efficacy time point PET or 14 days beyond the last day of study drug administration The post-treatment follow-up period began the day after completion of the treatment period and ended on the day of the patients last contact date within the study
Following treatment and Week 28 evaluations eligible patients who tolerated study drug could elect to enroll in an open-label extension study 301012-CS6 Patients who were not eligible for or who elected not to enroll in the open-label extension study and patients who discontinued during the 26-week treatment period were followed in this study for an additional 24 weeks from administration of the last dose of study drug
Mipomersen ISIS 301012 is an antisense drug that reduces a protein in the liver cells called apolipoprotein B apo-B Apo-B plays a role in producing low density lipoprotein cholesterol the bad cholesterol and moving it from the liver to ones bloodstream High LDL-C is an independent risk factor for the development of coronary heart disease CHD or other diseases of blood vessels It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events
This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period with the exception of patients who enrolled in the open-label extension study Study 301012-CS6 NCT00694109 The treatment period spanned the time during which the study treatment was administered until the later of the primary efficacy time point PET or 14 days beyond the last day of study drug administration The post-treatment follow-up period began the day after completion of the treatment period and ended on the day of the patients last contact date within the study
Following treatment and Week 28 evaluations eligible patients who tolerated study drug could elect to enroll in an open-label extension study 301012-CS6 Patients who were not eligible for or who elected not to enroll in the open-label extension study and patients who discontinued during the 26-week treatment period were followed in this study for an additional 24 weeks from administration of the last dose of study drug
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