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

Sponsor:	Provident Clinical Research
Collaborator:	Reliant Pharmaceuticals
Information provided by:	Provident Clinical Research
ClinicalTrials.gov Identifier:	NCT00678743

Purpose

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.

Condition	Intervention	Phase
Mixed Dyslipidemia	Drug: Omacor + simvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Omacor

U.S. FDA Resources

Further study details as provided by Provident Clinical Research:

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 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	August 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678743

Sponsors and Collaborators

Provident Clinical Research

Reliant Pharmaceuticals

Investigators

Study Director:

Kevin C. Maki, PhD

Provident Clinical Research

More Information

No publications provided

Responsible Party:	Provident Clinical Research ( Kevin C. Maki, PhD, Chief Science Officer )
Study ID Numbers:	PRV-06009X
Study First Received:	May 14, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00678743 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Provident Clinical Research:

cholesterol
dyslipidemia
omega 3

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010