Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-02 @ 12:57 AM
Study NCT ID:
NCT00532558
Status:
TERMINATED
Last Update Posted:
2012-05-24
First Post:
2007-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating 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 vs Placebo in Subjects With Hypercholesterolemia, With an Optional Open-Label Extension
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents
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 reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).
Detailed Description:
This study is being conducted to determine the potential of lapaquistat acetate 50 mg per day to lower LDL-C levels compared with placebo. This study is also being conducted to further evaluate the safety and tolerability of lapaquistat acetate 50 mg over a period of 12 weeks. An optional, 48-week, open-label extension will follow the 12 week, double-blind treatment period to evaluate the long-term safety and tolerability of lapaquistat acetate 50 mg/day.
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 |
|---|---|---|---|---|
| U1111-1122-8417 | REGISTRY | WHO | View |