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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00703482




Registration number
NCT00703482
Ethics application status
Date submitted
20/06/2008
Date registered
23/06/2008
Date last updated
25/06/2008

Titles & IDs
Public title
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes
Secondary ID [1] 0 0
CFEN0205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients With Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fenofibrate/CoQ10
Treatment: Drugs - Fenofibrate/CoQ10
Treatment: Drugs - Fenofibrate/CoQ10
Treatment: Drugs - Fenofibrate/CoQ10
Treatment: Drugs - Fenofibrate/CoQ10
Treatment: Drugs - Fenofibrate/CoQ10
Treatment: Drugs - Fenofibrate/CoQ10

Placebo comparator: 1 -

Active comparator: 2 -

Active comparator: 3 -

Experimental: 4 -

Experimental: 5 -

Experimental: 6 -

Experimental: 7 -


Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate pbo/CoQ10 placebo

Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate pbo/CoQ10 200 mg

Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 placebo

Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate 80/CoQ10 100 mg

Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 100 mg

Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate 80 /CoQ10 200 mg

Treatment: Drugs: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 200 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evolution of the E'/E septal ratio
Timepoint [1] 0 0
End of study (V6)
Secondary outcome [1] 0 0
Severity of the LVDD
Timepoint [1] 0 0
End of study (V6)
Secondary outcome [2] 0 0
Evolution of the Left atrium and right atrium volumes
Timepoint [2] 0 0
End of study (V6)
Secondary outcome [3] 0 0
Evolution of the Left and right sizes
Timepoint [3] 0 0
End of study (V6)
Secondary outcome [4] 0 0
Evolution of the LVEDD and LVESD
Timepoint [4] 0 0
End of study (V6)
Secondary outcome [5] 0 0
Evolution of the LVEDV and LVESV
Timepoint [5] 0 0
End of study (V6)
Secondary outcome [6] 0 0
Evolution of the LV mass
Timepoint [6] 0 0
End of study (V6)
Secondary outcome [7] 0 0
Evolution of the LV ejection fraction
Timepoint [7] 0 0
End of study (V6)
Secondary outcome [8] 0 0
Evolution of the IVRT
Timepoint [8] 0 0
End of study (V6)
Secondary outcome [9] 0 0
Evolution of the tissue Doppler E'/A' ratio
Timepoint [9] 0 0
End of study (V6)
Secondary outcome [10] 0 0
Evolution of the PV doppler parameters
Timepoint [10] 0 0
End of study (V6)

Eligibility
Key inclusion criteria
* Men or women aged from 40 to 79 years
* Patients with pre-existing T2DM
* HbA1C <9%
* Written informed consent
Minimum age
40 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unable to comply with the protocol, Likely to leave the trial before completion
* having participated in an another trial 3à days before V1
* Pregnant or childbearing potential not using birth control method
* Type 1 diabetic patients, T2Dm insulin therapy

Patients with one of the following pathology:

* with muscular disorders known or increase CK , or hepatic deficiency or transaminase increase
* with symptomatic gall-bladder disease or/and renal insufficiency
* with abnormal thyroid function
* with proliferative retinopathy
* with recent cardiovascular event, uncontrolled hypertension
* with known chronic alcohol intake
* with other severe pathology
* with TC>= 7.0 mmol/L and/or TG>= 4mmol/L at V1
* Patients treated with Warfarin
* Patients with specific ECG dysfunction

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2004
Sample size
Target
Accrual to date
Final
278
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site 002 - Fremantle
Recruitment hospital [2] 0 0
Site 003 - Nedlands
Recruitment hospital [3] 0 0
Site 001 - Perth
Recruitment postcode(s) [1] 0 0
- Fremantle
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Solvay Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Global Clinical Director Solvay
Address 0 0
Solvay Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00703482