Status:
COMPLETED
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
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Patients With Type 2 Diabetes
Eligibility:
All Genders
40-79 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Men or women aged from 40 to 79 years
- Patients with pre-existing T2DM
- HbA1C \<9%
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00703482
Start Date
May 1 2003
End Date
September 1 2004
Last Update
June 25 2008
Active Locations (3)
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1
Site 002
Fremantle, Australia
2
Site 003
Nedlands, Australia
3
Site 001
Perth, Australia