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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

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
History of Changes
  Purpose

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 Intervention Phase
Patients With Type 2 Diabetes
 Drug: Fenofibrate/CoQ10
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Evolution of the E'/E septal ratio [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 278
Study Start Date: May 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jean Claude Ansquer, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703482     History of Changes
Other Study ID Numbers: CFEN0205
Study First Received: June 20, 2008
Last Updated: June 24, 2008
Health Authority: Australia: National Health and Medical Research Council

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on May 19, 2013