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Not Yet RecruitingPhase 3ACTRN12605000777695

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

Sponsor

Fournier Laboratories Ireland

Enrollment

400 participants

Start Date

Dec 15, 2005

Study Type

Interventional

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.

Eligibility

Sex: Both males and females

Inclusion Criteria1

  • 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 Criteria1

  • Diabetes, CK>2 times ULN, creatinine clearance > 80ml/min, LFTs >2 times ULN.

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Interventions

Coprescription fenofibrate 145mg and simvastatin 40mg

Coprescription fenofibrate 145mg and simvastatin 40mg

Locations(1)

France

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ACTRN12605000777695