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Trial registered on ANZCTR


Registration number
ACTRN12606000377538
Ethics application status
Approved
Date submitted
22/08/2006
Date registered
29/08/2006
Date last updated
7/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Biomarker Sub-study to the VYTUL Study
Scientific title
A comparison of the Effects of Vytorin (Ezetimibe and Simvastatin) versus Lipitor (Atorvastatin) in inducing changes to levels of novel serum biomarkers associated with Coronary Heart Disease risk.
Universal Trial Number (UTN)
Trial acronym
VYTUL - Biomarker Sub-study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia 1344 0
Condition category
Condition code
Blood 1433 1433 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration of Vytorin 10/40 (Ezetimibe 10 mg and Simvastatin 40 mg) intervention group
Intervention code [1] 1161 0
Treatment: Drugs
Comparator / control treatment
Lipitor (Atorvastatin 80 mg) control group taken daily orally for six weeks.
Control group
Active

Outcomes
Primary outcome [1] 1965 0
To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: C Reactive Protein (CRP)
Timepoint [1] 1965 0
At a single time point after 6 weeks of treatment
Primary outcome [2] 1966 0
To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: B-Type Natriuretic Peptide (BNP)
Timepoint [2] 1966 0
At a single time point after 6 weeks of treatment
Primary outcome [3] 1967 0
To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Matrix Metalloproteinase (MMP)
Timepoint [3] 1967 0
At a single time point after 6 weeks of treatment
Primary outcome [4] 1968 0
To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Lipoprotein-associated phospholipase A2 (Lp-PLA2)
Timepoint [4] 1968 0
At a single time point after 6 weeks of treatment
Primary outcome [5] 1969 0
To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Oxidised low density lipoprotein (oxLDL)
Timepoint [5] 1969 0
At a single time point after 6 weeks of treatment
Primary outcome [6] 1970 0
To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Tumour Necrosis Factor alpha (TNFa).
Timepoint [6] 1970 0
At a single time point after 6 weeks of treatment
Secondary outcome [1] 3432 0
To explore non-physiological external issues such as participant awareness of their health and its management and any perceived barriers to health care that may contribute to ineffective risk factor modification.
Timepoint [1] 3432 0
This will be performed at the screening visit before cholesterol testing is performed and before treatment .

Eligibility
Key inclusion criteria
Participation in the VYTUL study- Capable of and willing to sign written informed consent- Has been treated for at least the last 3 months with a daily dose of atorvastatin40 mg- Existing coronary heart disease and has cholesterol > 4.0 mmol/L measured at Visit 1 OR diabetes mellitus and has measured at Visit 1• cholesterol > 6.5 mmol/L OR• cholesterol > 5.5 mmol/L and HDL < 1 mmol/L- Free of any clinically significant diseases, other than hyperlipidaemia, that would interfere with study evaluations and willing and able to attend all study visits.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled diabetes, defined by a measured HbA1c > 9% as measured at Visit 1-Has alanine aminotransferase (ALT) > 1.5 times Upper Limit of Normal (ULN) as measured at Visit 1- Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at Visit 1-Has creatine kinase (CK) > 1.5 times ULN as measured at Visit 1- Has triglycerides (TG) > 4.5 mmol/L as measured at Visit 1- Has evidence of renal impairment with a serum creatinine > 200 µmol/L as measured at Visit 1- Has known drug or alcohol dependency within 6 months prior to Visit 1-A woman receiving hormonal therapy, including hormone replacement, anyestrogen antagonist/agonist, or oral contraceptives, who have not beenmaintained on a stable dose and regimen for at least 8 weeks and are willingto continue the same regimen for the duration of the study.- A woman of childbearing potential (includes women who are less than 1 yearpostmenopausal or not surgically sterile) not using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condomin combination with spermicide)- Women who are pregnant or breast feeding- Any condition or situation which, in the opinion of the investigator, might pose arisk to the subject or interfere with participation in the studyProhibited Medication for the Duration of the Study- Medications taken within 5 weeks prior to Visit 1 (Screening Visit) including: macrolide antibiotics, azole antifungals, fibric acid derivatives, niacin- Other medication as listed in the product information sheets for ezetimibe/simvastatin and atorvastatin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation 1:1 ratio. Blok stratified by site
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1565 0
University
Name [1] 1565 0
Department of Epidemilogy and Preventive Medicine CCRE in Therapeutics Monash University
Country [1] 1565 0
Australia
Primary sponsor type
University
Name
Deartment of Epidemiology and Preventive Medicine CCRE in Therapeutics Monash University
Address
Country
Australia
Secondary sponsor category [1] 1377 0
None
Name [1] 1377 0
NA
Address [1] 1377 0
Country [1] 1377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2998 0
Monash University Clinical Trials Centre Caulfield General Medical Centre
Ethics committee address [1] 2998 0
Ethics committee country [1] 2998 0
Australia
Date submitted for ethics approval [1] 2998 0
Approval date [1] 2998 0
31/07/2006
Ethics approval number [1] 2998 0
162/06

Summary
Brief summary
Investigator initiated separate sub-study to the VYTUL study to measure novel serum biomarkers associated with increased heart disease risk to ascertain whether these biomarkers are predictive of response in this population and whether further work on targeting these biomarkers is warranted.
A second part to the substudy will focus on exploring non-physiological external factors that may contribute to ineffective risk factor modification and ultimately increased CHD risk in this population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35593 0
Address 35593 0
Country 35593 0
Phone 35593 0
Fax 35593 0
Email 35593 0
Contact person for public queries
Name 10350 0
Ms Louise Shiel - Project Manager
Address 10350 0
Monash University
Department of Epidemiology and Preventive Medicine - CCRE in Therapeutics
Clinical Trials Centre
260 Kooyong Road
CAULFIELD VIC 3162
Country 10350 0
Australia
Phone 10350 0
+61 3 9276 6166
Fax 10350 0
+61 3 9276 6249
Email 10350 0
louise.shiel@med.monash.edu.au
Contact person for scientific queries
Name 1278 0
Associate Professor Chris Reid - Co principal investigator
Address 1278 0
Monash University
Department of Epidemiology and Preventive Medicine - CCRE in Therapeutics
Level 3 Burnet Bldg
89 Commercial Rd MELBOURNE VIC 3004
Country 1278 0
Australia
Phone 1278 0
+61 3 9903 0752
Fax 1278 0
Email 1278 0
chris.reid@med.monash.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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