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

Provident Clinical Research

Status and phase: Completed; Phase 4

Conditions: Dyslipidemias

Treatments: Drug: Omacor + simvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00678743

PRV-06009X

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Omacor 4 grams/day plus simvastatin 80 mg/day.

Other group

Description:

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.

Treatment:

Drug: Omacor + simvastatin