A multicenter, double-blind, randomized study to compare the efficacy and safety of the combination of 145mg fenofibrate and simvastatin with 40mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 40 mg simvastatin alone
Phase 3
- Conditions
- Patients with mixed dyslipidemia with CHD or CHD risk equivalent or with multiple risk factor and a 10 year risk above or equal to 10% and with TG above 1.71mmol/l and LDL >2.58 or >3.36mmol/l according to risk after 6 weeks of treatment with 40mg simvastatin.Blood - Other blood disorders
- Registration Number
- ACTRN12605000777695
- Lead Sponsor
- Fournier Laboratories Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Patients with mixed dyslipidemia with CHD or CHD risk equivalent or with multiple risk factor and a 10 year risk above or equal to 10% and with TG above 1.71mmol/l and LDL >2.58 or >3.36mmol/l according to risk after 6 weeks of treatment with 40mg simvastatin.
Exclusion Criteria
Diabetes, CK>2 times ULN, creatinine clearance > 80ml/min, LFTs >2 times ULN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TG[At 6 months];LDL-C[At 6 months]
- Secondary Outcome Measures
Name Time Method on-HDL-C, Total Cholesterol, ApoA1, AopB, hsCRP.[];Fibrinogen[At 6 months.]