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

NCT00678743 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-05-29

Study results available
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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.

Conditions

  • Dyslipidemias

Interventions

DRUG

Omacor + simvastatin

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

Sponsors & Collaborators

  • Reliant Pharmaceuticals

    collaborator INDUSTRY

  • Provident Clinical Research

    lead OTHER

Principal Investigators

  • Kevin C. Maki, PhD · Provident Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-08-31
Completion
2009-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678743 on ClinicalTrials.gov