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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

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patients With Type 2 Diabetes

Intervention: Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug); Fenofibrate/CoQ10 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Evolution of the E'/E septal ratio

Secondary outcome:

Severity of the LVDD

Evolution of the Left atrium and right atrium volumes

Evolution of the Left and right sizes

Evolution of the LVEDD and LVESD

Evolution of the LVEDV and LVESV

Evolution of the LV mass

Evolution of the LV ejection fraction

Evolution of the IVRT

Evolution of the tissue Doppler E'/A' ratio

Evolution of the PV doppler parameters

Eligibility

Minimum age: 40 Years. Maximum age: 79 Years. Gender(s): Both.

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

Locations and Contacts

Site 002, Fremantle, Australia

Site 003, Nedlands, Australia

Site 001, Perth, Australia

Additional Information

Starting date: May 2003
Last updated: June 24, 2008

Page last updated: August 23, 2015

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