Status:
COMPLETED
An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
Lead Sponsor:
Provident Clinical Research
Collaborating Sponsors:
Reliant Pharmaceuticals
Conditions:
Dyslipidemias
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
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 curren...
Eligibility Criteria
Inclusion
- 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
- Study drug compliance less than 50% in PRV-06009
- Any ongoing serious adverse event from PRV-06009
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00678743
Start Date
August 1 2007
End Date
September 1 2009
Last Update
May 29 2025
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