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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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000777695
Enrollment
400
Registered
2005-12-07
Start date
2005-12-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Coprescription fenofibrate 145mg and simvastatin 40mg

Sponsors

Fournier Laboratories Ireland
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026