Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353522
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2006-07-17
Brief Title:
A Study of RO4607381 in Patients With Coronary Heart Disease CHD or a CHD Risk Equivalent
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-controlled Parallel Group Study Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease or CHD risk equivalent After a pre-randomization phase of 5-12 weeks patients will be randomized to receive either RO4607381 900mg po or placebo po daily for 24 weeks with concomitant atorvastatin 10-80mg daily and changes in cholesterol level and lipoprotein metabolism will be measured The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
Detailed Description:
None
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