A Randomised, Double-Blind, Placebo-Controlled Study Asse... | NCT00703482

Studies
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

NCT00703482

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Jun 25, 2008Estimated

Enrollment

278Actual

Phase

Phase 2

Conditions

Patients With Type 2 Diabetes

Interventions

Fenofibrate/CoQ10
Fenofibrate/CoQ10
Fenofibrate/CoQ10
Fenofibrate/CoQ10
Fenofibrate/CoQ10
Fenofibrate/CoQ10
Fenofibrate/CoQ10

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Sep 2004Actual

Completion Date

Sep 2004Actual

First Submitted Date

Jun 20, 2008

First Submission Date that Met QC Criteria

Jun 20, 2008

First Posted Date

Jun 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2008

Last Update Posted Date

Jun 25, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Placebo Comparator	Drug: Fenofibrate/CoQ10
2	Active Comparator	Drug: Fenofibrate/CoQ10
3	Active Comparator	Drug: Fenofibrate/CoQ10
4	Experimental	Drug: Fenofibrate/CoQ10
5	Experimental	Drug: Fenofibrate/CoQ10
6	Experimental	Drug: Fenofibrate/CoQ10
7	Experimental	Drug: Fenofibrate/CoQ10

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fenofibrate/CoQ10	Drug	Fenofibrate pbo/CoQ10 placebo	1
Fenofibrate/CoQ10

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of the E'/E septal ratio		End of study (V6)

Secondary Outcomes

Measure	Description	Time Frame
Severity of the LVDD		End of study (V6)
Evolution of the Left atrium and right atrium volumes		End of study (V6)
Evolution of the Left and right sizes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 002		Fremantle			Australia
Site 003

ID	Term
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D011345	Fenofibrate
C024989	coenzyme Q10

Ancestor Terms

ID	Term
D058607	Fibric Acids
D058610	Isobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010647	Phenyl Ethers
D004987	Ethers
D001577	Benzophenones
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010636	Phenols
D007659	Ketones