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

Provident Clinical Research17 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemias

Interventions

Omacor + simvastatinDRUG

Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Median % Change in Non-HDL-C From Baseline to 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.

Time frame: Week 6

Secondary Outcomes

Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin

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

Time frame: 52 weeks

Median % Change in Non-HDL-C From Baseline to Week 104

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

Time frame: 104 weeks

Data from ClinicalTrials.gov

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