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Completed

NCT Number: NCT00703482

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

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Key information

Conditions

Patients With Type 2 Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 002, Fremantle, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fenofibrate/CoQ10

Drug

Fenofibrate pbo/CoQ10 placebo

Primary outcomes

  1. Evolution of the E'/E septal ratio

    Time frame: End of study (V6)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 23, 2008
Registry last updated
Jun 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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