An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
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
1 other identifier
interventional
17
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2007
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 14, 2008
CompletedFirst Posted
Study publicly available on registry
May 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
May 29, 2025
CompletedMay 29, 2025
May 1, 2025
2 years
May 14, 2008
April 11, 2024
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median % Change in Non-HDL-C From Baseline to Week 6
The primary efficacy endpoint will be the median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to Week 6 of PRV-06009X. Briefly, non-HDL-C was measured at Weeks -2, -1, and 0 from blood samples, and the concentrations of non-HDL-C in the blood at these timepoints were averaged to obtain baseline non-HDL-C concentration. Similarly, non-HDLC was measured at Week 6 from blood samples. Statistical analysis was performed comparing the change in non-HDL-C concentration from baseline to Week 6 and presented herein.
Week 6
Secondary Outcomes (2)
Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin
52 weeks
Median % Change in Non-HDL-C From Baseline to Week 104
104 weeks
Study Arms (1)
Omacor 4 grams/day plus simvastatin 80 mg/day.
OTHERSubjects 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.
Interventions
Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Eligibility Criteria
You may not qualify if:
- Must have completed the previous double-blind study to week 12.
- Provide written informed consent and authorization for protected health information
- Study drug compliance less than 50% in PRV-06009
- Any ongoing serious adverse event from PRV-06009
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Provident Clinical Researchlead
- Reliant Pharmaceuticalscollaborator
Related Publications (1)
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.
PMID: 21297494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Potential limitations: 1) small sample size, 2) short duration of each treatment period
Results Point of Contact
- Title
- John Marshall, General Manager
- Organization
- Biofortis Research (formerly Provident)
Study Officials
- STUDY DIRECTOR
Kevin C. Maki, PhD
Provident Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Director/Chief Science Officer
Study Record Dates
First Submitted
May 14, 2008
First Posted
May 16, 2008
Study Start
August 1, 2007
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
May 29, 2025
Results First Posted
May 29, 2025
Record last verified: 2025-05