Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143663
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2005-08-31
Brief Title:
Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Double-blind Randomized Study to Evaluate the Efficacy and Safety of TAK-475 100 mg Versus Placebo 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 determine if patients with elevated cholesterol but not taking any other lipid medication could lower their cholesterol with administration of lapaquistat acetate once daily QD
Detailed Description:
This study will evaluate the efficacy and safety of TAK-475 lapaquistat acetate compared to placebo in subjects with primary hypercholesterolemia Subjects who have signed the informed consent will undergo necessary evaluations to determine eligibility for a dietary run-in phase Subjects who meet randomization criteria will enter treatment with one of the following randomized treatments lapaquistat acetate or placebo
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 |
|---|---|---|---|
| U1111-1122-7722 | REGISTRY | WHO | None |