Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-28 @ 5:23 PM
Study NCT ID:
NCT00249912
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2005-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg, 100 mg or Placebo When Coadministered With Rosuvastatin 10 mg or 20 mg in Subjects With Primary 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 rosuvastatin 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 rosuvastatin will be more efficacious in lowering low-density lipoprotein cholesterol, compared to lapaquistat or rosuvastatin alone. Total participation time in this study is anticipated to be 24 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 rosuvastatin will be more efficacious in lowering low-density lipoprotein cholesterol, compared to lapaquistat or rosuvastatin alone. Total participation time in this study is anticipated to be 24 weeks.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1122-8106 | REGISTRY | WHO | View |