Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268697
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2005-12-20
Brief Title:
Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Double-Blind Double-Dummy Randomized Parallel Group Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg and Lapaquistat Acetate 100 mg Administered in Combination With Ezetimibe 10 mg vs Ezetimibe 10 mg in Subjects With Primary Dyslipidemia
Status:
COMPLETED
Status Verified Date:
2012-05
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:
The purpose of the study is to determine the efficacy of lapaquistat acetate once daily QD taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia
Detailed Description:
In humans cholesterol is acquired from dietary sources and is produced de novo in the liver intestine and various other tissues Normally the balance among cholesterol synthesis dietary intake and degradation is adequate to maintain healthy cholesterol plasma levels however in subjects with hypercholesterolemia elevation in low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls atherosclerosis and subsequent coronary heart disease Thus it has been established that lowering the low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality Additional lipid risk factors for coronary heart disease include elevated triglyceride very low-density lipoprotein cholesterol and low-density lipoprotein cholesterol levels and low levels of high-density lipoprotein cholesterol
Despite changes in lifestyle and the availability of potent lipid-lowering agents cardiovascular disease continues to be the major cause of death in Western Europe and North America Serum cholesterol levels exceeding 5 mmolL 193 mgdL are common in adults in Britain and much of Europe the United States Australia and New Zealand representing a serious public health concern
Currently 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ie statins are the first-line monotherapies prescribed for the treatment of dyslipidemia after diet and therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to desired levels Statins reduce low-density lipoprotein cholesterol and triglycerides increase high-density lipoprotein cholesterol and improve endothelial function Treatment with statins reduces the risk of a vascular event by about 30 in subjects with and without symptoms of arteriosclerosis however many subjects fail to reach recommended levels of low-density lipoprotein cholesterol reduction after receiving low-dose statins as a monotherapy Consequently the dosage of statins is often increased or an additional treatment is added the latter has become an important therapeutic option for achieving increasingly stringent lipid targets set forth by international therapeutic guidelines
Ezetimibe is a lipid-lowering compound that selectively inhibits intestinal absorption of cholesterol at the brush border of the small intestine leading to a decrease in the delivery of intestinal cholesterol to the liver Ezetimibe does not affect the absorption of triglycerides fatty acids bile acids progesterone ethinylestradiol or fat-soluble vitamins A and D
TAK-475 lapaquistat acetate is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia This study will evaluate the efficacy and safety of lapaquistat acetate taken with ezetimibe in subjects with hypercholesterolemia Total participation time in this study is expected to be up to 24 weeks
Despite changes in lifestyle and the availability of potent lipid-lowering agents cardiovascular disease continues to be the major cause of death in Western Europe and North America Serum cholesterol levels exceeding 5 mmolL 193 mgdL are common in adults in Britain and much of Europe the United States Australia and New Zealand representing a serious public health concern
Currently 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ie statins are the first-line monotherapies prescribed for the treatment of dyslipidemia after diet and therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to desired levels Statins reduce low-density lipoprotein cholesterol and triglycerides increase high-density lipoprotein cholesterol and improve endothelial function Treatment with statins reduces the risk of a vascular event by about 30 in subjects with and without symptoms of arteriosclerosis however many subjects fail to reach recommended levels of low-density lipoprotein cholesterol reduction after receiving low-dose statins as a monotherapy Consequently the dosage of statins is often increased or an additional treatment is added the latter has become an important therapeutic option for achieving increasingly stringent lipid targets set forth by international therapeutic guidelines
Ezetimibe is a lipid-lowering compound that selectively inhibits intestinal absorption of cholesterol at the brush border of the small intestine leading to a decrease in the delivery of intestinal cholesterol to the liver Ezetimibe does not affect the absorption of triglycerides fatty acids bile acids progesterone ethinylestradiol or fat-soluble vitamins A and D
TAK-475 lapaquistat acetate is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia This study will evaluate the efficacy and safety of lapaquistat acetate taken with ezetimibe in subjects with hypercholesterolemia Total participation time in this study is expected to be up to 24 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-002315-25 | EUDRACT_NUMBER | None | None |
| U1111-1122-8322 | REGISTRY | WHO | None |