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

Mixed Dyslipidemia Clinical Trial

Official title:

An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate Simvastatin 20 mg Plus Omacor 4g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00678743
• Other study ID #: PRV-06009X
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 14, 2008
• Last updated: May 14, 2008
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: May 2008
• Source: Provident Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 vists.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Mixed Dyslipidemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Provident Clinical Research	Reliant Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint will be the percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to Week 6 of PRV-06009X		Week 6	No
Secondary	The percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to week 52 of PRV-06009X open-label treatment		52 weeks	No
Secondary	The percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to week 104 of PRV-06009X open-label treatment		104 weeks	No