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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

NCT ID: NCT00703482

Last Updated: 2008-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Patients With Type 2 Diabetes

Keywords

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Ventricular diastolic Function Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate pbo/CoQ10 placebo

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate 160mg/CoQ10 placebo

2

Group Type ACTIVE_COMPARATOR

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate pbo/CoQ10 200 mg

3

Group Type ACTIVE_COMPARATOR

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate 160mg/CoQ10 placebo

4

Group Type EXPERIMENTAL

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate 80/CoQ10 100 mg

5

Group Type EXPERIMENTAL

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate 160mg/CoQ10 100 mg

6

Group Type EXPERIMENTAL

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate 80 /CoQ10 200 mg

7

Group Type EXPERIMENTAL

Fenofibrate/CoQ10

Intervention Type DRUG

Fenofibrate 160mg/CoQ10 200 mg

Interventions

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Fenofibrate/CoQ10

Fenofibrate pbo/CoQ10 placebo

Intervention Type DRUG

Fenofibrate/CoQ10

Fenofibrate pbo/CoQ10 200 mg

Intervention Type DRUG

Fenofibrate/CoQ10

Fenofibrate 160mg/CoQ10 placebo

Intervention Type DRUG

Fenofibrate/CoQ10

Fenofibrate 80/CoQ10 100 mg

Intervention Type DRUG

Fenofibrate/CoQ10

Fenofibrate 160mg/CoQ10 100 mg

Intervention Type DRUG

Fenofibrate/CoQ10

Fenofibrate 80 /CoQ10 200 mg

Intervention Type DRUG

Fenofibrate/CoQ10

Fenofibrate 160mg/CoQ10 200 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 002

Fremantle, , Australia

Site Status

Site 003

Nedlands, , Australia

Site Status

Site 001

Perth, , Australia

Site Status

Countries

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Australia

Other Identifiers

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CFEN0205

Identifier Type: -

Identifier Source: org_study_id