Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435045
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2007-02-13
Brief Title:
Evaluation of Efficacy and Safety of Omacor Co-Administered With Atorvastatin in Subjects With Hypertriglyceridemia
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Forced Titration Study to Assess the Efficacy and Safety of Omacor Co-Administered With Open-Label Atorvastatin Therapy in Hypertriglyceridemic Subjects
Status:
COMPLETED
Status Verified Date:
2016-12
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 evaluate the efficacy and safety of Omacor omega-3-acid ethyl esters combined with atorvastatin for lowering non-high-density lipoprotein cholesterol non-HDL-C in hypertriglyceridemic subjects
Detailed Description:
Randomized double-blind placebo-controlled parallel-group study design with eleven clinic visits one screening visit three lead-inbaseline visits and seven treatment visits After a 4-week diet only lead-in period subjects with a triglyceride TG level in the high to very high range and with non-HDL-C level above NCEP ATPIII goals will be randomized to receive either open-label atorvastatin 10 mg per day plus double-blinded Lovaza 4g 4 x 1g capsules per day OR open-label atorvastatin 10 mg per day plus a double-blinded matching placebo 4 corn oil capsules per day for 8 weeks After the initial 8-week treatment period the dose of open-label atorvastatin will be titrated to 20 mg per day with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day for an additional 4 weeks At Week 12 a second open-label titration to 40 mg of open-label atorvastatin per day will be maintained for an additional 4 weeks again with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day
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