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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000777695 |
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Date of registration:
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07/12/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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15/12/2005 |
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Target sample size:
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400 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000777695.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Francis Roy
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Address:
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Laboratoires Fournier SA
50 rue de Dijon
21121 Daix
France |
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Telephone:
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+33 3 80447582 |
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Email:
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f.roy@fr.fournierpharma.com |
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Affiliation:
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Name:
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Dr Martine Guy
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Address:
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Laboratoires Fournier SA
50 rue de Dijon
21121 Daix
France |
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Telephone:
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+33 3 80447583 |
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Email:
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m.guy@fr.fournierpharma.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Blood - Other blood disorders
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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.;
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.
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Intervention(s)
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Coprescription fenofibrate 145mg and simvastatin 40mg
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Primary Outcome(s)
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LDL-C[At 6 months]
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TG[At 6 months]
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Secondary Outcome(s)
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Fibrinogen[At 6 months.]
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Non-HDL-C, Total Cholesterol, ApoA1, AopB, hsCRP.[]
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Source(s) of Monetary Support
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Fournier Laboratories Ireland
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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