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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

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ClinicalTrials.gov Identifier: NCT00703482
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : June 25, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Patients With Type 2 Diabetes Drug: Fenofibrate/CoQ10 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Drug: Fenofibrate/CoQ10
Fenofibrate pbo/CoQ10 placebo

Drug: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 placebo

Active Comparator: 2 Drug: Fenofibrate/CoQ10
Fenofibrate pbo/CoQ10 200 mg

Active Comparator: 3 Drug: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 placebo

Experimental: 4 Drug: Fenofibrate/CoQ10
Fenofibrate 80/CoQ10 100 mg

Experimental: 5 Drug: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 100 mg

Experimental: 6 Drug: Fenofibrate/CoQ10
Fenofibrate 80 /CoQ10 200 mg

Experimental: 7 Drug: Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 200 mg




Primary Outcome Measures :
  1. Evolution of the E'/E septal ratio [ Time Frame: End of study (V6) ]

Secondary Outcome Measures :
  1. Severity of the LVDD [ Time Frame: End of study (V6) ]
  2. Evolution of the Left atrium and right atrium volumes [ Time Frame: End of study (V6) ]
  3. Evolution of the Left and right sizes [ Time Frame: End of study (V6) ]
  4. Evolution of the LVEDD and LVESD [ Time Frame: End of study (V6) ]
  5. Evolution of the LVEDV and LVESV [ Time Frame: End of study (V6) ]
  6. Evolution of the LV mass [ Time Frame: End of study (V6) ]
  7. Evolution of the LV ejection fraction [ Time Frame: End of study (V6) ]
  8. Evolution of the IVRT [ Time Frame: End of study (V6) ]
  9. Evolution of the tissue Doppler E'/A' ratio [ Time Frame: End of study (V6) ]
  10. Evolution of the PV doppler parameters [ Time Frame: End of study (V6) ]


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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703482


Locations
Australia
Site 002
Fremantle, Australia
Site 003
Nedlands, Australia
Site 001
Perth, Australia
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Jean Claude Ansquer, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703482     History of Changes
Other Study ID Numbers: CFEN0205
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: June 25, 2008
Last Verified: June 2008

Keywords provided by Solvay Pharmaceuticals:
Ventricular diastolic Function
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Fenofibrate
Coenzyme Q10
Ubiquinone
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins