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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00703482
First received: June 20, 2008
Last updated: June 24, 2008
Last verified: June 2008

June 20, 2008
June 24, 2008
May 2003
September 2004   (final data collection date for primary outcome measure)
Evolution of the E'/E septal ratio [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00703482 on ClinicalTrials.gov Archive Site
  • Severity of the LVDD [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the Left atrium and right atrium volumes [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the Left and right sizes [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the LVEDD and LVESD [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the LVEDV and LVESV [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the LV mass [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the LV ejection fraction [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the IVRT [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the tissue Doppler E'/A' ratio [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
  • Evolution of the PV doppler parameters [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Patients With Type 2 Diabetes
  • Drug: Fenofibrate/CoQ10
    Fenofibrate pbo/CoQ10 placebo
  • Drug: Fenofibrate/CoQ10
    Fenofibrate pbo/CoQ10 200 mg
  • Drug: Fenofibrate/CoQ10
    Fenofibrate 160mg/CoQ10 placebo
  • Drug: Fenofibrate/CoQ10
    Fenofibrate 80/CoQ10 100 mg
  • Drug: Fenofibrate/CoQ10
    Fenofibrate 160mg/CoQ10 100 mg
  • Drug: Fenofibrate/CoQ10
    Fenofibrate 80 /CoQ10 200 mg
  • Drug: Fenofibrate/CoQ10
    Fenofibrate 160mg/CoQ10 200 mg
  • Placebo Comparator: 1
    Interventions:
    • Drug: Fenofibrate/CoQ10
    • Drug: Fenofibrate/CoQ10
  • Active Comparator: 2
    Intervention: Drug: Fenofibrate/CoQ10
  • Active Comparator: 3
    Intervention: Drug: Fenofibrate/CoQ10
  • Experimental: 4
    Intervention: Drug: Fenofibrate/CoQ10
  • Experimental: 5
    Intervention: Drug: Fenofibrate/CoQ10
  • Experimental: 6
    Intervention: Drug: Fenofibrate/CoQ10
  • Experimental: 7
    Intervention: Drug: Fenofibrate/CoQ10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
September 2004
September 2004   (final data collection date for primary outcome measure)

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
Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00703482
CFEN0205
No
Jean Claude Ansquer, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP