Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504829
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2007-07-18
Brief Title:
Study of AtorvastatinFenofibrate LCP-AtorFen Combination Therapy in Dyslipidemia
Sponsor:
Veloxis Pharmaceuticals
Organization:
Veloxis Pharmaceuticals
Study Overview
Official Title:
A 12-Week Multi-Center Double-Blind Randomized Parallel-Group Study Followed by a 12 Month Extension Study of the Efficacy and Safety of LCP-AtorFen in Subjects With Dyslipidemia
Status:
COMPLETED
Status Verified Date:
2020-02
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 current study is designed to test the efficacy safety and tolerability of LCP-AtorFen a combination of atorvastatin and fenofibrate
Detailed Description:
This is a multicenter randomized double-blind 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen the combination of atorvastatin and fenofibrate in the treatment of hyperlipidemia
After a wash-out phase eligible patients will be randomized on a 111 ratio to either LCP-AtorFen atorvastatin or fenofibrate for 12 weeks After the completion of the 12-week phase all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks
After a wash-out phase eligible patients will be randomized on a 111 ratio to either LCP-AtorFen atorvastatin or fenofibrate for 12 weeks After the completion of the 12-week phase all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks
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