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Trial registered on ANZCTR


Registration number
ACTRN12606000031561
Ethics application status
Approved
Date submitted
19/01/2006
Date registered
20/01/2006
Date last updated
20/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
C FEN 0205
Scientific title
a randomised, double-blind, placebo-controlled study assessing the effect of fenofibrate, coenzyme Q10 and their co-administration on ventricular disatolic function in patients with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes with left ventricular diastolic dysfunction (LVDD) 994 0
Condition category
Condition code
Metabolic and Endocrine 1069 1069 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
fenofibrate 80mg + CoEnz Q10 100mg
fenofibrate 80mg + CoEnz Q10 200mg
fenofibrate 160mg + CoEnz Q10 100mg
fenofibrate 160mg + CoEnz Q10 200mg
fenofibrate 160mg
CoEnz Q10 200mg

6 MONTHS INTERVENTION
Intervention code [1] 849 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1432 0
E to E' ratio on cardioechocardiography
Timepoint [1] 1432 0
Evaluation performed at the end of the 6 months period of treatment
Secondary outcome [1] 2534 0
Classification of patients according to the severity of LVDD.
Timepoint [1] 2534 0

Eligibility
Key inclusion criteria
Type 2 diabetes patients with LVDD and LV ejection fraction equal or greater than 50%.
Minimum age
40 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serum creatinine above 130 micromol/l, ALT/AST above 2xULN, CK above 3xULN.

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)
Decoding enveloppes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation was generated by computer and restricted by blocks. After randomisation, treatments were allocated to the patients following order of randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1169 0
Commercial sector/Industry
Name [1] 1169 0
Fournier Laboratories Ireland
Address [1] 1169 0
Country [1] 1169 0
Primary sponsor type
Commercial sector/Industry
Name
Fournier Laboratory Ireland
Address
Country
Ireland
Secondary sponsor category [1] 1030 0
None
Name [1] 1030 0
None
Address [1] 1030 0
Country [1] 1030 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36245 0
Address 36245 0
Country 36245 0
Phone 36245 0
Fax 36245 0
Email 36245 0
Contact person for public queries
Name 10038 0
Patrick Aubonnet
Address 10038 0
Laboratoires Fournier SA
Level 1
Building 2
20 Bridge Street
Pymble NSW 2073
Country 10038 0
Australia
Phone 10038 0
+61 2 94979727
Fax 10038 0
+61 2 94401382
Email 10038 0
p.aubonnet@au.fournierpharma.com
Contact person for scientific queries
Name 966 0
Patrick Aubonnet
Address 966 0
Laboratoires Fournier SA
Level 1
Building 2
20 Bridge Street
Pymble NSW 2073
Country 966 0
Australia
Phone 966 0
+61 2 94979727
Fax 966 0
+61 2 94401382
Email 966 0
p.aubonnet@au.fournierpharma.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary