None listed
Conditions
Brief 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.
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 in Australia.
Sponsors
Merck Sharp & Dohme Australia & Schering-Plough Pty. Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Capable of and willing to sign written informed consent- Has been treated for at least the last 3 months with a daily dose of atorvastatin40 mg- Existing coronary heart disease and has cholesterol > 4.0 mmol/L measured at Visit 1 OR diabetes mellitus and has measured at Visit 1• cholesterol > 6.5 mmol/L OR• cholesterol > 5.5 mmol/L and HDL < 1 mmol/L- Free of any clinically significant diseases, other than hyperlipidaemia, that would interfere with study evaluations and willing and able to attend all study visits.
Exclusion criteria
Uncontrolled diabetes, defined by a measured HbA1c > 9% as measured at Visit 1-Has alanine aminotransferase (ALT) > 1.5 times Upper Limit of Normal (ULN) as measured at Visit 1- Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at Visit 1-Has creatine kinase (CK) > 1.5 times ULN as measured at Visit 1- Has triglycerides (TG) > 4.5 mmol/L as measured at Visit 1- Has evidence of renal impairment with a serum creatinine > 200 µmol/L as measured at Visit 1- Has known drug or alcohol dependency within 6 months prior to Visit 1-A woman receiving hormonal therapy, including hormone replacement, anyestrogen antagonist/agonist, or oral contraceptives, who have not beenmaintained on a stable dose and regimen for at least 8 weeks and are willingto continue the same regimen for the duration of the study.- A woman of childbearing potential (includes women who are less than 1 yearpostmenopausal or not surgically sterile) not using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condomin combination with spermicide)- Women who are pregnant or breast feeding- Any condition or situation which, in the opinion of the investigator, might pose arisk to the subject or interfere with participation in the studyProhibited Medication for the Duration of the Study- Medications taken within 5 weeks prior to Visit 1 (Screening Visit) including: macrolide antibiotics, azole antifungals, fibric acid derivatives, niacin- Other medication as listed in the product information sheets for ezetimibe/simvastatin and atorvastatin.
Outcome results
None listed