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

Primary Purpose

Mixed Dyslipidemia

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Omacor + simvastatin

About this trial

This is an interventional treatment trial for Mixed Dyslipidemia focused on measuring cholesterol, dyslipidemia, omega 3

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00678743

First Posted

May 14, 2008

Last Updated

May 14, 2008

Sponsor

Provident Clinical Research

Collaborators

Reliant Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00678743

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

August 2007 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Provident Clinical Research

Collaborators

Reliant Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mixed Dyslipidemia

Keywords

cholesterol, dyslipidemia, omega 3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Omacor + simvastatin

Other Intervention Name(s)

Omega-3-acid ethyl esters, Lovaza, Zocor

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

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

Time Frame

52 weeks

Title

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

Time Frame

104 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin C. Maki, PhD

Organizational Affiliation

Provident Clinical Research

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

21297494

Citation

Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94. doi: 10.1097/FJC.0b013e318210fca5.

Results Reference

derived

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

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