Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286481
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2006-02-01
Brief Title:
Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Factorial Study to Evaluate the Efficacy and Safety of Lapaquistat and Simvastatin Alone and in Combination in Subjects With Hypercholesterolemia
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 this study is to evaluate lapaquistat acetate once daily QD taken alone or with simvastatin on cholesterol levels in treating patients with elevated cholesterol
Detailed Description:
Elevated plasma cholesterol hypercholesterolemia and various other plasma lipid imbalances dyslipidemias are major risk factors for coronary heart disease Patients with hypercholesterolemia have elevated low-density lipoprotein cholesterol which leads to atherosclerotic deposition of cholesterol in the arterial walls As identified by the National Cholesterol Education Program Adult Treatment Panel III lowering the low-density lipoprotein cholesterol plasma concentration effectively reduces cardiovascular morbidity and mortality and is essential for the prevention and management of coronary heart disease
Currently 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors statins are the first-line monotherapies prescribed to reduce low-density lipoprotein cholesterol after diet and therapeutic lifestyle change However low doses of statins often fail to produce the ATP III-recommended levels of low-density lipoprotein cholesterol reduction making it necessary to increase the dose or add an additional treatment Dose increases of statins in turn may result in decreased tolerability and potential safety concerns which contribute to the high discontinuation rates of statins and their prescription at low and often ineffective doses
The purpose of this study is to determine whether administration of lapaquistat acetate co-administered with simvastatin will be more efficacious in lowering low-density lipoprotein cholesterol compared to lapaquistat or simvastatin alone Total participation time in this study is anticipated to be 19 weeks
Currently 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors statins are the first-line monotherapies prescribed to reduce low-density lipoprotein cholesterol after diet and therapeutic lifestyle change However low doses of statins often fail to produce the ATP III-recommended levels of low-density lipoprotein cholesterol reduction making it necessary to increase the dose or add an additional treatment Dose increases of statins in turn may result in decreased tolerability and potential safety concerns which contribute to the high discontinuation rates of statins and their prescription at low and often ineffective doses
The purpose of this study is to determine whether administration of lapaquistat acetate co-administered with simvastatin will be more efficacious in lowering low-density lipoprotein cholesterol compared to lapaquistat or simvastatin alone Total participation time in this study is anticipated to be 19 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 |
|---|---|---|---|
| U1111-1122-7978 | REGISTRY | WHO | None |