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An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00487591
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : May 7, 2008
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
Provident Clinical Research

Tracking Information
First Submitted Date June 14, 2007
First Posted Date June 18, 2007
Last Update Posted Date May 7, 2008
Study Start Date November 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2007)
Change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Baseline to end of treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2007)
Changes in other lipid and biomarker levels [ Time Frame: Baseline through end of treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
Official Title An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
Brief Summary The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.
Detailed Description This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum and plasma
Sampling Method Not Provided
Study Population Not Provided
Condition Mixed Dyslipidemia
Intervention
  • Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin
    Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)
    Other Name: Lovaza
  • Drug: simvastatin plus placebo
    simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo
Study Groups/Cohorts
  • Simva+Omacor
    Intervention: Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin
  • Simva + Placebo
    Intervention: Drug: simvastatin plus placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2007)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men and women, ages 18-79 inclusive
  • Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
  • Fasting, untreated triglyceride (TG) level in the high to very high range
  • Provide written informed consent and authorization for protected health information

Exclusion Criteria:

  • Pregnancy
  • Use of lipid-altering drugs which cannot be stopped
  • History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
  • Body mass index above 40 kg per square meter
  • Allergy or sensitivity to omega-3 fatty acids or to statin drugs
  • Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
  • Certain muscle, liver, kidney, lung or gastrointestinal conditions
  • Certain medications
  • Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00487591
Other Study ID Numbers PRV-06009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research
Study Sponsor Provident Clinical Research
Collaborators Reliant Pharmaceuticals
Investigators
Study Director: Kevin C Maki, PhD Provident Clinical Research
PRS Account Provident Clinical Research
Verification Date April 2008