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

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Provident Clinical Research
• Collaborator: Reliant Pharmaceuticals
• Treatments: Simvastatin

Criteria

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