RecruitingPhase 4ACTRN12606000374561

VYTUL

A multi-centre, randomised, open-label parallel groups study comparing the effectiveness and safety of treatment with Vytorin (Ezetimibe and Simvastatin) versus Lipitor (Atorvastatin) in subjects with a history of coronary heart disease and/or diabetes mellitus with uncontrolled lipids on statin therapy.


Sponsor

Merck Sharp & Dohme Australia & Schering-Plough Pty. Limited

Enrollment

550 participants

Start Date

Sep 1, 2006

Study Type

Interventional

Conditions

Summary

To determine if the introduction of Vytorin will be more effective than increasing the dose of Atorvastain in achieving LDL ('bad cholesterol') and other cholesterol level goals in high risk patients who have been treated for at least the last three months with atorvastatin 40 mg and still have uncontrolled cholesterol levels.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two different approaches to lowering 'bad' cholesterol (LDL cholesterol) in people whose levels are too high despite already being on a common cholesterol medication called atorvastatin 40mg. The two options being compared are: switching to a combination pill called Vytorin (which contains two cholesterol-lowering drugs together) or increasing the dose of atorvastatin alone. The study aims to see which approach is more effective at bringing cholesterol down to safe target levels in people at high risk of heart disease. You may be eligible if: - You are 18 years of age or older - You have been taking atorvastatin 40mg daily for at least 3 months - You have existing coronary heart disease with cholesterol above 4.0 mmol/L, OR you have diabetes with cholesterol above certain levels - You are otherwise in good health with no significant other diseases You may NOT be eligible if: - Your diabetes is uncontrolled (HbA1c above 9%) - You have elevated liver enzymes or creatine kinase (muscle enzyme) in blood tests - You have high triglycerides (blood fat) above 4.5 mmol/L - You have significant kidney problems - You have a drug or alcohol dependency in the last 6 months - You are pregnant, breastfeeding, or a woman of childbearing age not using reliable contraception - You have taken certain medications such as fibrates, niacin, or antifungals in the past 5 weeks Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The duration of the study will be approximately 8 weeks involving 4 visits. Randomisation to treatment groups: Vytorin 10/40 (Ezetimibe 10mg /Simvastatin 40mg) ; both these medications are registered

The duration of the study will be approximately 8 weeks involving 4 visits. Randomisation to treatment groups: Vytorin 10/40 (Ezetimibe 10mg /Simvastatin 40mg) ; both these medications are registered in Australia.


Locations(1)

Australia

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ACTRN12606000374561


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