| Trial ID: | L2144 |
| Source ID: | NCT00703482
|
| Associated Drug: |
Fenofibrate/Coq10
|
| 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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Patients With Type 2 Diabetes
|
| Interventions: |
DRUG: Fenofibrate/CoQ10|DRUG: Fenofibrate/CoQ10|DRUG: Fenofibrate/CoQ10|DRUG: Fenofibrate/CoQ10|DRUG: Fenofibrate/CoQ10|DRUG: Fenofibrate/CoQ10|DRUG: Fenofibrate/CoQ10
|
| Outcome Measures: |
Primary: Evolution of the E'/E septal ratio, End of study (V6) | Secondary: 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)|Evolution of the LV mass, End of study (V6)|Evolution of the LV ejection fraction, End of study (V6)|Evolution of the IVRT, End of study (V6)|Evolution of the tissue Doppler E'/A' ratio, End of study (V6)|Evolution of the PV doppler parameters, End of study (V6)
|
| Sponsor/Collaborators: |
Sponsor: Solvay Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
278
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2003-05
|
| Completion Date: |
2004-09
|
| Results First Posted: |
|
| Last Update Posted: |
2008-06-25
|
| Locations: |
Site 002, Fremantle, Australia|Site 003, Nedlands, Australia|Site 001, Perth, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT00703482
|
