Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000777695
Ethics application status
Approved
Date submitted
30/11/2005
Date registered
7/12/2005
Date last updated
7/12/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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. 933 0
Condition category
Condition code
Blood 1002 1002 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coprescription fenofibrate 145mg and simvastatin 40mg
Intervention code [1] 780 0
None
Comparator / control treatment
Simvastatin 40mg
Control group
Active

Outcomes
Primary outcome [1] 1338 0
TG
Timepoint [1] 1338 0
At 6 months
Primary outcome [2] 1339 0
LDL-C
Timepoint [2] 1339 0
At 6 months
Secondary outcome [1] 2382 0
Non-HDL-C, Total Cholesterol, ApoA1, AopB, hsCRP.
Timepoint [1] 2382 0
Secondary outcome [2] 2383 0
Fibrinogen
Timepoint [2] 2383 0
At 6 months.

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes, CK>2 times ULN, creatinine clearance > 80ml/min, LFTs >2 times ULN.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment will be assigned at the randomisation visit (V2) to patients compliant with the inclusion/exclusion/randomisation criteria by a centralised randomisation centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation by computer software using four block-balanced randomisation lists (one for male patients with the highest level of CVD risk, one for male patients with the lowest level of risk, one for female patients with the highest level of risk and one for female patients with the lowest level of risk).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 247 0
France
State/province [1] 247 0

Funding & Sponsors
Funding source category [1] 1100 0
Commercial sector/Industry
Name [1] 1100 0
Fournier Laboratories Ireland
Country [1] 1100 0
Ireland
Primary sponsor type
Commercial sector/Industry
Name
Fournier Laboratories Ireland
Address
Country
Ireland
Secondary sponsor category [1] 967 0
None
Name [1] 967 0
None
Address [1] 967 0
Country [1] 967 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35714 0
Address 35714 0
Country 35714 0
Phone 35714 0
Fax 35714 0
Email 35714 0
Contact person for public queries
Name 9969 0
Dr Martine Guy
Address 9969 0
Laboratoires Fournier SA
50 rue de Dijon
21121 Daix
Country 9969 0
France
Phone 9969 0
+33 3 80447583
Fax 9969 0
Email 9969 0
m.guy@fr.fournierpharma.com
Contact person for scientific queries
Name 897 0
Francis Roy
Address 897 0
Laboratoires Fournier SA
50 rue de Dijon
21121 Daix
Country 897 0
France
Phone 897 0
+33 3 80447582
Fax 897 0
Email 897 0
f.roy@fr.fournierpharma.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.