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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The purpose of this study was to study the effect of different combinations of fenofibrate
and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes
Trial website
https://clinicaltrials.gov/ct2/show/NCT00703482
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00703482