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
1 other identifier
interventional
278
1 country
3
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2003
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedJune 25, 2008
June 1, 2008
1.3 years
June 20, 2008
June 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of the E'/E septal ratio
End of study (V6)
Secondary Outcomes (10)
Severity of the LVDD
End of study (V6)
Evolution of the Left atrium and right atrium volumes
End of study (V6)
Evolution of the Left and right sizes
End of study (V6)
Evolution of the LVEDD and LVESD
End of study (V6)
Evolution of the LVEDV and LVESV
End of study (V6)
- +5 more secondary outcomes
Study Arms (7)
1
PLACEBO COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATOR4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTAL7
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Men or women aged from 40 to 79 years
- Patients with pre-existing T2DM
- HbA1C \<9%
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Site 002
Fremantle, Australia
Site 003
Nedlands, Australia
Site 001
Perth, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 23, 2008
Study Start
May 1, 2003
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
June 25, 2008
Record last verified: 2008-06