Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251680
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2005-11-08
Brief Title:
Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Placebo-Controlled Double-Blind Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in Subjects With Type 2 Diabetes Currently Treated With Lipid-Lowering Therapy
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 established lipid-lowering therapy in subjects with type 2 diabetes mellitus
Detailed Description:
Diabetes mellitus is a recognized cause of secondary dyslipidemia and is also independently considered to be a major cardiovascular risk factor requiring aggressive lipid-lowering treatment Type 2 diabetes accounts for 85 to 90 of diabetes worldwide It affects about 2 of the Caucasian population in most Westernized countries and the prevalence rises with age to 10 in those over 70 years of age Five percent or more of young- and middle-aged adults in some Asian or Afro-Caribbean groups in the United Kingdom have this condition Approximately 12 million Americans have type 2 diabetes and an estimated 20 million more have some degree of glucose intolerance The greatest cause of mortality in type 2 diabetes is atherosclerotic vascular disease and its sequelae between 75 and 80 of adult subjects with diabetes die of macrovascular complications
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 co-administered with an established lipid-lowering therapy including atorvastatin simvastatin rosuvastatin or fenofibrate in subjects with type 2 diabetes mellitus
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 co-administered with an established lipid-lowering therapy including atorvastatin simvastatin rosuvastatin or fenofibrate in subjects with type 2 diabetes mellitus
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 |
|---|---|---|---|
| U1111-1122-8281 | REGISTRY | WHO | None |
| 2005-002316-24 | EUDRACT_NUMBER | None | None |