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
Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients With Type 2 Diabetes
Intervention: Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s): Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Evolution of the E'/E septal ratio
Secondary outcome: Severity of the LVDDEvolution of the Left atrium and right atrium volumes Evolution of the Left and right sizes Evolution of the LVEDD and LVESD Evolution of the LVEDV and LVESV Evolution of the LV mass Evolution of the LV ejection fraction Evolution of the IVRT Evolution of the tissue Doppler E'/A' ratio Evolution of the PV doppler parameters
Eligibility
Minimum age: 40 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men or women aged from 40 to 79 years
- Patients with pre-existing T2DM
- HbA1C <9%
- Written informed consent
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
Locations and Contacts
Site 002, Fremantle, Australia
Site 003, Nedlands, Australia
Site 001, Perth, Australia
Additional Information
Starting date: May 2003
Last updated: June 24, 2008
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