An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin

Phase 4

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Omacor + simvastatin

• Registration Number: NCT00678743
• Lead Sponsor: Provident Clinical Research

Brief Summary

The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.

Detailed Description

The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits.

The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study:

* Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial.

* Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Results First Submitted: 2024-04-11
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Results First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (PRV-06009)
• Must have completed the previous double-blind study to week 12.
• Provide written informed consent and authorization for protected health information

Exclusion Criteria

• Study drug compliance less than 50% in PRV-06009
• Any ongoing serious adverse event from PRV-06009

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omacor 4 grams/day plus simvastatin 80 mg/day.	Omacor + simvastatin	Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.

Primary Outcome Measures

Name	Time	Method
Median % Change in Non-HDL-C From Baseline to Week 6	Week 6	The primary efficacy endpoint will be the median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to Week 6 of PRV-06009X.; Briefly, non-HDL-C was measured at Weeks -2, -1, and 0 from blood samples, and the concentrations of non-HDL-C in the blood at these timepoints were averaged to obtain baseline non-HDL-C concentration. Similarly, non-HDLC was measured at Week 6 from blood samples. Statistical analysis was performed comparing the change in non-HDL-C concentration from baseline to Week 6 and presented herein.

Secondary Outcome Measures

Name	Time	Method
Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin	52 weeks	The median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to week 52 of PRV-06009X open-label treatment
Median % Change in Non-HDL-C From Baseline to Week 104	104 weeks	The median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to week 104 of PRV-06009X open-label treatment